Obesity
Conditions
Keywords
behavioral intervention, JITAI (just-in-time adaptive intervention)
Brief summary
Mobile obesity interventions have the potential to reach a diverse population in need; however, while effective, have not resulted in weight losses obtained in in-person interventions. Newer digital approaches called Just-in-Time Adaptive Interventions (JITAI) that offer adaptive, personalized feedback 'when needed' and in 'real time' offer an opportunity to use digital health tools just in time. This study seeks to identify the optimal components of a comprehensive weight loss JITAI that results in weight losses that meet or exceed those in existing remotely delivered interventions.
Detailed description
Obesity has reached epidemic proportions in the United States and is recognized as a major cause of morbidity and mortality. Young adults (18-35 years) are at particularly high risk for weight gain and obesity. In-person behavioral interventions generally produce clinically significant weight losses; however, cost and access limit their potential to reduce obesity at a population level. Although web-based interventions that mimic the structure of weekly face-to-face treatment have proven a viable alternative treatment, weight losses are generally smaller than in-person treatment. Exclusively mobile treatments have been less effective, producing 1-3 kgs over 6 months. Newer digital intervention approaches called Just-in-Time Adaptive Interventions (JITAIs) promise to improve upon outcomes by offering adaptive, personalized feedback on behavior when needed in real time, rather than on a fixed schedule. This just-in-time, or JIT, approach is made possible by the emergence of low-cost and widely available digital health tools that allow for the collection of continually updated health data. However, few studies have used JIT approaches in remotely delivered, fully scalable weight loss interventions. Although JITAIs are a potentially transformative approach to delivering obesity interventions, a major obstacle in their development is efficient selection of components and systematic design of an optimized intervention package that produces clinically meaningful weight losses with a population-level strategy. To solve this problem, this trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to identify which levels of 5 intervention components contribute meaningfully to change in weight over 6 months among young adults with overweight and obesity. All participants (n=608) will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation will lead to greater weight loss, participants will be randomized to standard versus more adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Candidate components have been carefully selected from empirical evidence, tested in prior studies conducted by the research team, or in a pilot micro-randomized trial conducted by the research team. Assessments will occur at 0, 3 and 6 months to accomplish the following specific aims: 1) Build an optimized JITAI consisting of the set of intervention components that yield the greatest improvement in weight change among young adults at 6 months; 2) Conduct mediation analyses to test the relationships between the intervention components and hypothesized proximal mediators (self-regulation, competence, relatedness, relevance, autonomy) and more distal behavioral mediators (dietary intake, physical activity, and daily self-weighting); and 3) Conduct exploratory analyses of program engagement.
Interventions
BEHAVIORALCore
Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
BEHAVIORALStandard Diet Monitoring
Standard monitoring using smartphone tracking of all calorie intake.
BEHAVIORALSimplified Diet Monitoring
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
BEHAVIORALAdaptive Activity Goals (Daily)
Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
BEHAVIORALAdaptive Activity Goals (Weekly)
Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
BEHAVIORALMessage Decision Points (Fixed)
Message timing is fixed and evaluated at specific times each day to determine message eligibility.
BEHAVIORALMessage Decision Points (Adaptive)
Message timing is adaptive and derived from individual user data to determine message eligibility.
BEHAVIORALMessage Decision Rules (Standard)
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
BEHAVIORALMessage Decision Rules (Adaptive)
Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
BEHAVIORALMessage Choice (No)
Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
BEHAVIORALMessage Choice (Yes)
Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study uses a full factorial experimental design testing the efficacy of five intervention components, each with two levels
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* body mass index (BMI) of 25-45 kg/m\^2 * English-speaking and writing * own a smartphone with a data and text messaging plan * willing to be randomized to any levels of the factors
Exclusion criteria
* Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes * Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis * Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4) * Lost 10 or more pounds (and kept it off) in the last 6 months * Currently taking weight loss medications * Report a past diagnosis of or current treatment for a DSM-V (Diagnostic and Statistical Manual 5) eating disorder (anorexia nervosa or bulimia nervosa) * Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months * Hospitalization for depression or other psychiatric disorder within the past 12 months * History of psychotic disorder or bipolar disorder * Another member of the household is a participant or staff member on this trial * Currently participating in a weight loss, nutrition or physical activity study or program or other study that would interfere with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight (kg) | Baseline, 6 months | Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Reaching >/= 5% Weight Loss | Baseline to 6 months | Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change. |
| Diet | Baseline, 6 months | Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint. Change calculated as (daily kcal at 6 months - daily kcal at baseline). |
| Physical Activity | Baseline,3 months, 6 months | Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Outcome is change in kcal burned per week. |
| Sedentary Behavior Score | Baseline, 3 months, 6 months | Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities. The scale ranges from none to 6 or more hours for each item. Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior. Range is 0 to 24 hours and outcome is change in minutes per day. |
| Autonomy Support Score | 3 months, 6 months | Autonomy support at 3 and 6 months. Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., I feel that \[the program\] has provided me choices and options.) Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Outcomes are the mean value at 3 months and the mean value at 6 months. |
| Competence for Diet and Physical Activity Scores | Baseline, 3 months, 6 months | Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as I feel confident in my ability to maintain a healthy diet. Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence for physical activity. |
| Weight (kg) | Baseline, 3 months | Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight). |
| Treatment Self-Regulation Score | Baseline, 3 months, 6 months | Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: Because I feel that I want to take responsibility for my own health answered on a scale of 1 (not at all true) to 7 (very true). Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months. |
| Relatedness Score | 3 months, 6 months | Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include The messages demonstrate caring about me as a person and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages. |
| Diet Self-monitoring Adherence | Baseline to 6 months (daily) | Mean number of days of complete dietary tracking summed over the 6-month study period. |
| Weighing Adherence | Baseline to 6 months (daily) | Mean number of days of self-weighing over the 6 month period. |
| Physical Activity Self-monitoring Adherence | Baseline to 6 months (daily) | Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear. |
| Perceived Message Relevance Score | 3 months, 6 months | Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages. Participants were asked to rate how strongly they disagree or agree with the statements about messages being written personally for me and applied to my life. Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The values of the two items are averaged for a final score. Higher values indicate that a participant perceives the messages received in the program are more relevant to them. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from Apr 2022 to Dec 2023; remote recruitment across the continental United States. 2510 individuals completed the online screening survey; 841 were initially eligible; out of those, 135 completed informed consent but were ineligible due to no longer being interested in participating or incomplete baseline measurement procedures, and 624 completed informed consent and all baseline assessment procedures and were randomized and enrolled in the study.
Pre-assignment details
Individuals who signed informed consent and then completed all baseline measurement procedures (online surveys and remote weight measurements) and remained eligible were considered enrolled and were randomized to 1 of 32 conditions.
Participants by arm
| Arm | Count |
|---|---|
| 1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 18 |
| 2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 21 |
| 3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 18 |
| 5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 18 |
| 7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 19 |
| 8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 18 |
| 14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Standard Diet Monitoring Standard monitoring using smartphone tracking of all calorie intake.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Daily) Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| 25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 19 |
| 26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Fixed) Message timing is fixed and evaluated at specific times each day to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Standard) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 20 |
| 31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (No) Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision | 20 |
| 32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
Behavioral: Simplified Diet Monitoring Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Behavioral: Adaptive Activity Goals (Weekly) Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
Behavioral: Message Decision Points (Adaptive) Message timing is adaptive and derived from individual user data to determine message eligibility.
Behavioral: Message Decision Rules (Adaptive) Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
Behavioral: Message Choice (Yes) Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision. | 19 |
| Total | 624 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 | 0 | 2 | 0 | 1 | 1 | 2 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 2 | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 1: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice | 2: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice | 3: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice | 4: Standard Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice | 5: Standard Diet Monitoring,Daily Adaptive Activity Goal, Adaptive Timing,Standard Rules,No Choice | 6: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice | 7:Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, No Choice | 8: Standard Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice | 9: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, No Choice | 10: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Standard Rules, Choice | 11: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, No Choice | 12: Standard Diet Monitoring, Weekly Activity Goal, Fixed Timing, Adaptive Rules, Choice | 13:Standard Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules,No Choice | 14:Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice | 15:Standard Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing, Adaptive Rules, No Choice | 16: Standard Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice | 17:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice | 18: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice | 19:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice | 20: Simplified Diet Monitoring, Daily Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice | 21:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Standard Rules, No Choice | 22:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice | 23:Simplified Diet Monitoring,Daily Adaptive Activity Goal,Adaptive Timing,Adaptive Rules, No Choice | 24:Simplified Diet Monitoring, Daily Adaptive Activity Goal, Adaptive Timing, Adaptive Rules, Choice | 25:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, No Choice | 26: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Standard Rules, Choice | 27:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, No Choice | 28: Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Fixed Timing, Adaptive Rules, Choice | 29:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Standard Rules,No Choice | 30:Simplified Diet Monitoring,Weekly Adaptive Activity Goal, Adaptive Timing, Standard Rules, Choice | 31:Simplified Diet Monitoring,Weekly Adaptive Activity Goal,Adaptive Timing,Adaptive Rules,No Choice | 32:Simplified Diet Monitoring, Weekly Adaptive Activity Goal, Adaptive Timing, Adaptive Rules,Choice | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 5.6 | 30.9 years STANDARD_DEVIATION 5.4 | 33.2 years STANDARD_DEVIATION 4.4 | 31.4 years STANDARD_DEVIATION 5 | 31.3 years STANDARD_DEVIATION 4.6 | 32.1 years STANDARD_DEVIATION 4.5 | 29.0 years STANDARD_DEVIATION 4.7 | 29.9 years STANDARD_DEVIATION 5.7 | 30.1 years STANDARD_DEVIATION 4.7 | 33.5 years STANDARD_DEVIATION 4 | 30.6 years STANDARD_DEVIATION 4.7 | 32.4 years STANDARD_DEVIATION 4.9 | 30.3 years STANDARD_DEVIATION 3.2 | 32.4 years STANDARD_DEVIATION 4.5 | 32.8 years STANDARD_DEVIATION 3.9 | 31.2 years STANDARD_DEVIATION 5.7 | 30.9 years STANDARD_DEVIATION 4.5 | 30.0 years STANDARD_DEVIATION 5.3 | 29.5 years STANDARD_DEVIATION 5.3 | 30.5 years STANDARD_DEVIATION 4.9 | 31.4 years STANDARD_DEVIATION 4.3 | 30.9 years STANDARD_DEVIATION 4.8 | 30.5 years STANDARD_DEVIATION 6 | 27.1 years STANDARD_DEVIATION 5.4 | 33.0 years STANDARD_DEVIATION 3.9 | 30.7 years STANDARD_DEVIATION 6.2 | 32.9 years STANDARD_DEVIATION 3.8 | 31.2 years STANDARD_DEVIATION 4.7 | 31.2 years STANDARD_DEVIATION 5 | 32.6 years STANDARD_DEVIATION 4.5 | 29.7 years STANDARD_DEVIATION 4.9 | 33.6 years STANDARD_DEVIATION 4.1 | 31.2 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 5 Participants | 4 Participants | 1 Participants | 2 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 18 Participants | 16 Participants | 15 Participants | 17 Participants | 17 Participants | 18 Participants | 17 Participants | 14 Participants | 16 Participants | 19 Participants | 16 Participants | 14 Participants | 18 Participants | 17 Participants | 18 Participants | 19 Participants | 17 Participants | 17 Participants | 16 Participants | 20 Participants | 13 Participants | 17 Participants | 17 Participants | 17 Participants | 18 Participants | 16 Participants | 19 Participants | 15 Participants | 16 Participants | 18 Participants | 17 Participants | 537 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 0 Participants | 5 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 0 Participants | 73 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 6 Participants | 1 Participants | 2 Participants | 5 Participants | 3 Participants | 5 Participants | 4 Participants | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 6 Participants | 2 Participants | 7 Participants | 2 Participants | 4 Participants | 1 Participants | 5 Participants | 8 Participants | 122 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 24 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 12 Participants | 13 Participants | 13 Participants | 9 Participants | 14 Participants | 15 Participants | 14 Participants | 11 Participants | 8 Participants | 15 Participants | 11 Participants | 10 Participants | 15 Participants | 9 Participants | 10 Participants | 8 Participants | 12 Participants | 7 Participants | 13 Participants | 10 Participants | 10 Participants | 13 Participants | 10 Participants | 14 Participants | 8 Participants | 14 Participants | 12 Participants | 13 Participants | 10 Participants | 9 Participants | 361 Participants |
| Sex/Gender, Customized Don't know | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 13 Participants | 14 Participants | 11 Participants | 12 Participants | 10 Participants | 9 Participants | 14 Participants | 14 Participants | 14 Participants | 16 Participants | 16 Participants | 11 Participants | 12 Participants | 9 Participants | 13 Participants | 11 Participants | 14 Participants | 15 Participants | 14 Participants | 16 Participants | 14 Participants | 14 Participants | 10 Participants | 14 Participants | 14 Participants | 14 Participants | 16 Participants | 13 Participants | 12 Participants | 12 Participants | 13 Participants | 14 Participants | 418 Participants |
| Sex/Gender, Customized Male | 4 Participants | 7 Participants | 9 Participants | 6 Participants | 9 Participants | 8 Participants | 5 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 8 Participants | 6 Participants | 10 Participants | 7 Participants | 8 Participants | 6 Participants | 5 Participants | 6 Participants | 3 Participants | 6 Participants | 5 Participants | 10 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 7 Participants | 8 Participants | 8 Participants | 7 Participants | 5 Participants | 203 Participants |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Weight (lb) | 207.7 pounds STANDARD_DEVIATION 52.3 | 208.5 pounds STANDARD_DEVIATION 35.1 | 206.8 pounds STANDARD_DEVIATION 45.1 | 214.9 pounds STANDARD_DEVIATION 38.7 | 210.5 pounds STANDARD_DEVIATION 41.5 | 212.1 pounds STANDARD_DEVIATION 36.3 | 195.7 pounds STANDARD_DEVIATION 36.5 | 200.3 pounds STANDARD_DEVIATION 43.3 | 203.1 pounds STANDARD_DEVIATION 33.4 | 208.8 pounds STANDARD_DEVIATION 33.2 | 195.2 pounds STANDARD_DEVIATION 32.4 | 224.4 pounds STANDARD_DEVIATION 36.2 | 190.8 pounds STANDARD_DEVIATION 28.5 | 233.9 pounds STANDARD_DEVIATION 45.6 | 218.2 pounds STANDARD_DEVIATION 39.8 | 185.7 pounds STANDARD_DEVIATION 34.3 | 200.7 pounds STANDARD_DEVIATION 49.7 | 195.0 pounds STANDARD_DEVIATION 47.7 | 219.5 pounds STANDARD_DEVIATION 53.4 | 201.5 pounds STANDARD_DEVIATION 41.8 | 206.1 pounds STANDARD_DEVIATION 36.3 | 211.0 pounds STANDARD_DEVIATION 39.6 | 207.5 pounds STANDARD_DEVIATION 45.6 | 216.3 pounds STANDARD_DEVIATION 45.1 | 210.6 pounds STANDARD_DEVIATION 33.6 | 203.8 pounds STANDARD_DEVIATION 40.4 | 203.0 pounds STANDARD_DEVIATION 37.1 | 200.9 pounds STANDARD_DEVIATION 33.9 | 218.3 pounds STANDARD_DEVIATION 42 | 198.5 pounds STANDARD_DEVIATION 22.3 | 206.0 pounds STANDARD_DEVIATION 49.8 | 215.8 pounds STANDARD_DEVIATION 33.5 | 207.2 pounds STANDARD_DEVIATION 40.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 21 | 0 / 20 | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 20 | 1 / 20 | 2 / 19 | 0 / 18 | 1 / 19 | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 20 | 2 / 19 | 0 / 20 | 1 / 19 | 0 / 20 | 0 / 19 | 1 / 19 | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 5 / 18 | 2 / 21 | 3 / 20 | 5 / 18 | 2 / 20 | 4 / 18 | 1 / 19 | 3 / 20 | 4 / 20 | 7 / 20 | 4 / 20 | 1 / 19 | 2 / 18 | 3 / 19 | 2 / 20 | 4 / 19 | 3 / 20 | 1 / 20 | 1 / 20 | 3 / 19 | 2 / 20 | 4 / 19 | 2 / 20 | 0 / 19 | 5 / 19 | 3 / 20 | 3 / 20 | 2 / 20 | 4 / 20 | 6 / 20 | 1 / 20 | 5 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 21 | 0 / 20 | 0 / 18 | 0 / 20 | 0 / 18 | 0 / 19 | 0 / 20 | 1 / 20 | 0 / 20 | 1 / 20 | 1 / 19 | 0 / 18 | 1 / 19 | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 20 | 2 / 19 | 0 / 20 | 1 / 19 | 0 / 20 | 0 / 19 | 1 / 19 | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Weight (kg)
Estimated mean weight change in kg from baseline to 6 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (6-month weight - baseline weight).
Time frame: Baseline, 6 months
Population: ITT: all randomized participants using all available weights.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Diet Monitoring | Weight (kg) | -3.61 kg |
| Simplified Diet Monitoring | Weight (kg) | -3.31 kg |
| Weekly Adaptive Activity Goals | Weight (kg) | -3.32 kg |
| Daily Adaptive Activity Goals | Weight (kg) | -3.60 kg |
| Fixed Message Decision Points | Weight (kg) | -3.66 kg |
| Adaptive Message Decision Points | Weight (kg) | -3.26 kg |
| Standard Message Decision Rules | Weight (kg) | -3.65 kg |
| Adaptive Message Decision Rules | Weight (kg) | -3.26 kg |
| No Message Choice | Weight (kg) | -3.19 kg |
| Message Choice | Weight (kg) | -3.73 kg |
Comparison: ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).p-value: 0.5295% CI: [-0.61, 1.2]Mixed Models Analysis
Comparison: ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).p-value: 0.5495% CI: [-1.19, 0.63]Mixed Models Analysis
Comparison: ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).p-value: 0.3995% CI: [-0.5, 1.31]Mixed Models Analysis
Comparison: ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).p-value: 0.795% CI: [-0.52, 1.3]Mixed Models Analysis
Comparison: ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).p-value: 0.4795% CI: [-1.45, 0.36]Mixed Models Analysis
Secondary
Autonomy Support Score
Autonomy support at 3 and 6 months. Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., I feel that \[the program\] has provided me choices and options.) Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Outcomes are the mean value at 3 months and the mean value at 6 months.
Time frame: 3 months, 6 months
Population: Participants who completed the Health Care Climate Questionnaire at 3 months; participants who completed the Health Care Climate Questionnaire at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Autonomy Support Score | 3 Months | 5.14 score on a scale | Standard Deviation 1.2 |
| Standard Diet Monitoring | Autonomy Support Score | 6 Months | 5.13 score on a scale | Standard Deviation 1.22 |
| Simplified Diet Monitoring | Autonomy Support Score | 3 Months | 5.11 score on a scale | Standard Deviation 1.11 |
| Simplified Diet Monitoring | Autonomy Support Score | 6 Months | 5.08 score on a scale | Standard Deviation 1.3 |
| Weekly Adaptive Activity Goals | Autonomy Support Score | 3 Months | 5.08 score on a scale | Standard Deviation 1.15 |
| Weekly Adaptive Activity Goals | Autonomy Support Score | 6 Months | 5.05 score on a scale | Standard Deviation 1.25 |
| Daily Adaptive Activity Goals | Autonomy Support Score | 3 Months | 5.17 score on a scale | Standard Deviation 1.15 |
| Daily Adaptive Activity Goals | Autonomy Support Score | 6 Months | 5.12 score on a scale | Standard Deviation 1.28 |
| Fixed Message Decision Points | Autonomy Support Score | 6 Months | 5.08 score on a scale | Standard Deviation 1.23 |
| Fixed Message Decision Points | Autonomy Support Score | 3 Months | 5.16 score on a scale | Standard Deviation 1.15 |
| Adaptive Message Decision Points | Autonomy Support Score | 6 Months | 5.11 score on a scale | Standard Deviation 1.26 |
| Adaptive Message Decision Points | Autonomy Support Score | 3 Months | 5.09 score on a scale | Standard Deviation 1.16 |
| Standard Message Decision Rules | Autonomy Support Score | 6 Months | 5.12 score on a scale | Standard Deviation 1.22 |
| Standard Message Decision Rules | Autonomy Support Score | 3 Months | 5.12 score on a scale | Standard Deviation 1.17 |
| Adaptive Message Decision Rules | Autonomy Support Score | 3 Months | 5.13 score on a scale | Standard Deviation 1.13 |
| Adaptive Message Decision Rules | Autonomy Support Score | 6 Months | 5.09 score on a scale | Standard Deviation 1.25 |
| No Message Choice | Autonomy Support Score | 3 Months | 5.13 score on a scale | Standard Deviation 1.15 |
| No Message Choice | Autonomy Support Score | 6 Months | 5.07 score on a scale | Standard Deviation 1.29 |
| Message Choice | Autonomy Support Score | 3 Months | 5.12 score on a scale | Standard Deviation 1.15 |
| Message Choice | Autonomy Support Score | 6 Months | 5.15 score on a scale | Standard Deviation 1.26 |
Secondary
Competence for Diet and Physical Activity Scores
Change in perceived competence from baseline to 3 and 6 months as measured using the The Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as I feel confident in my ability to maintain a healthy diet. Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence for physical activity.
Time frame: Baseline, 3 months, 6 months
Population: Participants who completed the Perceived Competence Scale for Diet at 3 months; participants who completed the Perceived Competence Scale for Diet at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.88 score on a scale | Standard Deviation 6.01 |
| Standard Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 2.03 score on a scale | Standard Deviation 6.76 |
| Standard Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -0.83 score on a scale | Standard Deviation 6.51 |
| Standard Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.14 score on a scale | Standard Deviation 6.67 |
| Simplified Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.62 score on a scale | Standard Deviation 6.81 |
| Simplified Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.74 score on a scale | Standard Deviation 6.36 |
| Simplified Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -1.18 score on a scale | Standard Deviation 6.57 |
| Simplified Diet Monitoring | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.50 score on a scale | Standard Deviation 6.09 |
| Weekly Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.74 score on a scale | Standard Deviation 6.75 |
| Weekly Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.41 score on a scale | Standard Deviation 6.17 |
| Weekly Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.10 score on a scale | Standard Deviation 6.37 |
| Weekly Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.87 score on a scale | Standard Deviation 6.65 |
| Daily Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 1.23 score on a scale | Standard Deviation 6.17 |
| Daily Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.90 score on a scale | Standard Deviation 6.83 |
| Daily Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.23 score on a scale | Standard Deviation 6.25 |
| Daily Adaptive Activity Goals | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.44 score on a scale | Standard Deviation 6.62 |
| Fixed Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.27 score on a scale | Standard Deviation 6.36 |
| Fixed Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.91 score on a scale | Standard Deviation 6.97 |
| Fixed Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.87 score on a scale | Standard Deviation 6.84 |
| Fixed Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.78 score on a scale | Standard Deviation 6.22 |
| Adaptive Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.06 score on a scale | Standard Deviation 6.26 |
| Adaptive Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.74 score on a scale | Standard Deviation 6.6 |
| Adaptive Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.84 score on a scale | Standard Deviation 6.15 |
| Adaptive Message Decision Points | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.45 score on a scale | Standard Deviation 6.41 |
| Standard Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 2.26 score on a scale | Standard Deviation 6.51 |
| Standard Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -0.92 score on a scale | Standard Deviation 6.28 |
| Standard Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.40 score on a scale | Standard Deviation 6.4 |
| Standard Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 1.32 score on a scale | Standard Deviation 5.66 |
| Adaptive Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.29 score on a scale | Standard Deviation 6.64 |
| Adaptive Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.92 score on a scale | Standard Deviation 6.86 |
| Adaptive Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.38 score on a scale | Standard Deviation 7.03 |
| Adaptive Message Decision Rules | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.42 score on a scale | Standard Deviation 6.33 |
| No Message Choice | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -0.31 score on a scale | Standard Deviation 7.03 |
| No Message Choice | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 0.62 score on a scale | Standard Deviation 6.05 |
| No Message Choice | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.02 score on a scale | Standard Deviation 6.55 |
| No Message Choice | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.81 score on a scale | Standard Deviation 6.83 |
| Message Choice | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 3 Months | -1.31 score on a scale | Standard Deviation 6.05 |
| Message Choice | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 3 Months | 1.00 score on a scale | Standard Deviation 6.32 |
| Message Choice | Competence for Diet and Physical Activity Scores | Competence for Physical Activity - Baseline to 6 Months | -1.03 score on a scale | Standard Deviation 6.2 |
| Message Choice | Competence for Diet and Physical Activity Scores | Competence for Diet - Baseline to 6 Months | 1.83 score on a scale | Standard Deviation 6.75 |
Secondary
Diet
Change in daily caloric intake from baseline to 6 months as measured using the self-administered National Cancer Institute's Automated Self- Administered 24-hour Recall (ASA-24), a 24-hour recall that is self-administered on a week day and a weekend day at each timepoint. Change calculated as (daily kcal at 6 months - daily kcal at baseline).
Time frame: Baseline, 6 months
Population: Participants who completed at least one 24-hour recall at 6 months (total N = 565).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Diet Monitoring | Diet | -378.6 kcal/day | Standard Deviation 765.8 |
| Simplified Diet Monitoring | Diet | -485.3 kcal/day | Standard Deviation 813.4 |
| Weekly Adaptive Activity Goals | Diet | -470.3 kcal/day | Standard Deviation 811.3 |
| Daily Adaptive Activity Goals | Diet | -391.9 kcal/day | Standard Deviation 768.8 |
| Fixed Message Decision Points | Diet | -452.3 kcal/day | Standard Deviation 807.2 |
| Adaptive Message Decision Points | Diet | -411.6 kcal/day | Standard Deviation 775.5 |
| Standard Message Decision Rules | Diet | -439.7 kcal/day | Standard Deviation 775.7 |
| Adaptive Message Decision Rules | Diet | -424.6 kcal/day | Standard Deviation 807.1 |
| No Message Choice | Diet | -476.9 kcal/day | Standard Deviation 841.6 |
| Message Choice | Diet | -386.7 kcal/day | Standard Deviation 735.3 |
Secondary
Diet Self-monitoring Adherence
Mean number of days of complete dietary tracking summed over the 6-month study period.
Time frame: Baseline to 6 months (daily)
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Diet Monitoring | Diet Self-monitoring Adherence | 73.3 days | Standard Deviation 51.3 |
| Simplified Diet Monitoring | Diet Self-monitoring Adherence | 67.9 days | Standard Deviation 48.1 |
| Weekly Adaptive Activity Goals | Diet Self-monitoring Adherence | 69.3 days | Standard Deviation 50.1 |
| Daily Adaptive Activity Goals | Diet Self-monitoring Adherence | 71.9 days | Standard Deviation 49.4 |
| Fixed Message Decision Points | Diet Self-monitoring Adherence | 69.2 days | Standard Deviation 49.1 |
| Adaptive Message Decision Points | Diet Self-monitoring Adherence | 72.1 days | Standard Deviation 50.4 |
| Standard Message Decision Rules | Diet Self-monitoring Adherence | 74.9 days | Standard Deviation 51.4 |
| Adaptive Message Decision Rules | Diet Self-monitoring Adherence | 66.3 days | Standard Deviation 47.6 |
| No Message Choice | Diet Self-monitoring Adherence | 69.7 days | Standard Deviation 50.4 |
| Message Choice | Diet Self-monitoring Adherence | 71.5 days | Standard Deviation 49 |
Secondary
Perceived Message Relevance Score
Perceived message relevance at 3 and 6 months as measured using two items used in our previous work and adapted from previous studies of tailored messages. Participants were asked to rate how strongly they disagree or agree with the statements about messages being written personally for me and applied to my life. Responses are on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The values of the two items are averaged for a final score. Higher values indicate that a participant perceives the messages received in the program are more relevant to them.
Time frame: 3 months, 6 months
Population: Participants who completed message relevance items at 3 months; participants who completed message relevance items at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Perceived Message Relevance Score | 6 Months | 3.36 score on a scale | Standard Deviation 1.01 |
| Standard Diet Monitoring | Perceived Message Relevance Score | 3 Months | 3.34 score on a scale | Standard Deviation 0.97 |
| Simplified Diet Monitoring | Perceived Message Relevance Score | 6 Months | 3.33 score on a scale | Standard Deviation 1.05 |
| Simplified Diet Monitoring | Perceived Message Relevance Score | 3 Months | 3.37 score on a scale | Standard Deviation 0.95 |
| Weekly Adaptive Activity Goals | Perceived Message Relevance Score | 6 Months | 3.35 score on a scale | Standard Deviation 0.99 |
| Weekly Adaptive Activity Goals | Perceived Message Relevance Score | 3 Months | 3.29 score on a scale | Standard Deviation 0.94 |
| Daily Adaptive Activity Goals | Perceived Message Relevance Score | 3 Months | 3.42 score on a scale | Standard Deviation 0.98 |
| Daily Adaptive Activity Goals | Perceived Message Relevance Score | 6 Months | 3.35 score on a scale | Standard Deviation 1.07 |
| Fixed Message Decision Points | Perceived Message Relevance Score | 3 Months | 3.35 score on a scale | Standard Deviation 0.98 |
| Fixed Message Decision Points | Perceived Message Relevance Score | 6 Months | 3.37 score on a scale | Standard Deviation 1.01 |
| Adaptive Message Decision Points | Perceived Message Relevance Score | 6 Months | 3.33 score on a scale | Standard Deviation 1.05 |
| Adaptive Message Decision Points | Perceived Message Relevance Score | 3 Months | 3.36 score on a scale | Standard Deviation 0.94 |
| Standard Message Decision Rules | Perceived Message Relevance Score | 6 Months | 3.34 score on a scale | Standard Deviation 1.04 |
| Standard Message Decision Rules | Perceived Message Relevance Score | 3 Months | 3.35 score on a scale | Standard Deviation 0.96 |
| Adaptive Message Decision Rules | Perceived Message Relevance Score | 3 Months | 3.36 score on a scale | Standard Deviation 0.96 |
| Adaptive Message Decision Rules | Perceived Message Relevance Score | 6 Months | 3.36 score on a scale | Standard Deviation 1.02 |
| No Message Choice | Perceived Message Relevance Score | 3 Months | 3.40 score on a scale | Standard Deviation 0.96 |
| No Message Choice | Perceived Message Relevance Score | 6 Months | 3.36 score on a scale | Standard Deviation 1.05 |
| Message Choice | Perceived Message Relevance Score | 6 Months | 3.33 score on a scale | Standard Deviation 1.01 |
| Message Choice | Perceived Message Relevance Score | 3 Months | 3.31 score on a scale | Standard Deviation 0.96 |
Secondary
Percent of Participants Reaching >/= 5% Weight Loss
Percent change in body weight will be calculated (6 month weight - baseline weight/100) and determined to be at or above 5% indicating a clinically significant change.
Time frame: Baseline to 6 months
Population: Participants with a 6-month weight value (total N = 583).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Diet Monitoring | Percent of Participants Reaching >/= 5% Weight Loss | 100 Participants |
| Simplified Diet Monitoring | Percent of Participants Reaching >/= 5% Weight Loss | 101 Participants |
| Weekly Adaptive Activity Goals | Percent of Participants Reaching >/= 5% Weight Loss | 89 Participants |
| Daily Adaptive Activity Goals | Percent of Participants Reaching >/= 5% Weight Loss | 112 Participants |
| Fixed Message Decision Points | Percent of Participants Reaching >/= 5% Weight Loss | 107 Participants |
| Adaptive Message Decision Points | Percent of Participants Reaching >/= 5% Weight Loss | 94 Participants |
| Standard Message Decision Rules | Percent of Participants Reaching >/= 5% Weight Loss | 101 Participants |
| Adaptive Message Decision Rules | Percent of Participants Reaching >/= 5% Weight Loss | 100 Participants |
| No Message Choice | Percent of Participants Reaching >/= 5% Weight Loss | 95 Participants |
| Message Choice | Percent of Participants Reaching >/= 5% Weight Loss | 106 Participants |
Comparison: Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).p-value: 0.9595% CI: [0.7, 1.39]Chi-squared
Comparison: Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).p-value: 0.0395% CI: [1.03, 2.05]Chi-squared
Comparison: Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).p-value: 0.3695% CI: [0.6, 1.2]Chi-squared
Comparison: Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).p-value: 0.9595% CI: [0.72, 1.42]Chi-squared
Comparison: Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).p-value: 0.2995% CI: [0.85, 1.69]Chi-squared
Secondary
Physical Activity
Change in physical activity from baseline to 3 and 6 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Outcome is change in kcal burned per week.
Time frame: Baseline,3 months, 6 months
Population: Participants who completed the PPAQ at 3 months; participants who completed the PPAQ at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Physical Activity | Baseline to 6 Months | 167.1 kcal/week | Standard Deviation 927.9 |
| Standard Diet Monitoring | Physical Activity | Baseline to 3 Months | 180.4 kcal/week | Standard Deviation 939.5 |
| Simplified Diet Monitoring | Physical Activity | Baseline to 3 Months | 322.6 kcal/week | Standard Deviation 1089.8 |
| Simplified Diet Monitoring | Physical Activity | Baseline to 6 Months | 92.1 kcal/week | Standard Deviation 861.5 |
| Weekly Adaptive Activity Goals | Physical Activity | Baseline to 3 Months | 252.1 kcal/week | Standard Deviation 967.1 |
| Weekly Adaptive Activity Goals | Physical Activity | Baseline to 6 Months | 128.0 kcal/week | Standard Deviation 899.1 |
| Daily Adaptive Activity Goals | Physical Activity | Baseline to 6 Months | 131.0 kcal/week | Standard Deviation 892.7 |
| Daily Adaptive Activity Goals | Physical Activity | Baseline to 3 Months | 250.8 kcal/week | Standard Deviation 1072.5 |
| Fixed Message Decision Points | Physical Activity | Baseline to 3 Months | 309.3 kcal/week | Standard Deviation 1074.4 |
| Fixed Message Decision Points | Physical Activity | Baseline to 6 Months | 163.6 kcal/week | Standard Deviation 911.8 |
| Adaptive Message Decision Points | Physical Activity | Baseline to 3 Months | 192.9 kcal/week | Standard Deviation 957.8 |
| Adaptive Message Decision Points | Physical Activity | Baseline to 6 Months | 94.4 kcal/week | Standard Deviation 878 |
| Standard Message Decision Rules | Physical Activity | Baseline to 3 Months | 268.0 kcal/week | Standard Deviation 1075.3 |
| Standard Message Decision Rules | Physical Activity | Baseline to 6 Months | 131.7 kcal/week | Standard Deviation 899.5 |
| Adaptive Message Decision Rules | Physical Activity | Baseline to 3 Months | 234.8 kcal/week | Standard Deviation 960.1 |
| Adaptive Message Decision Rules | Physical Activity | Baseline to 6 Months | 127.3 kcal/week | Standard Deviation 892.4 |
| No Message Choice | Physical Activity | Baseline to 6 Months | 102.9 kcal/week | Standard Deviation 854 |
| No Message Choice | Physical Activity | Baseline to 3 Months | 149.8 kcal/week | Standard Deviation 934.7 |
| Message Choice | Physical Activity | Baseline to 3 Months | 353.2 kcal/week | Standard Deviation 1089 |
| Message Choice | Physical Activity | Baseline to 6 Months | 156.6 kcal/week | Standard Deviation 936.2 |
Secondary
Physical Activity Self-monitoring Adherence
Mean number of days of physical activity tracking over the 6 month period as measured by Fitbit tracker wear.
Time frame: Baseline to 6 months (daily)
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Diet Monitoring | Physical Activity Self-monitoring Adherence | 134.1 days | Standard Deviation 46.5 |
| Simplified Diet Monitoring | Physical Activity Self-monitoring Adherence | 133.4 days | Standard Deviation 45.3 |
| Weekly Adaptive Activity Goals | Physical Activity Self-monitoring Adherence | 133.2 days | Standard Deviation 46.3 |
| Daily Adaptive Activity Goals | Physical Activity Self-monitoring Adherence | 134.3 days | Standard Deviation 45.4 |
| Fixed Message Decision Points | Physical Activity Self-monitoring Adherence | 132.7 days | Standard Deviation 46.7 |
| Adaptive Message Decision Points | Physical Activity Self-monitoring Adherence | 134.8 days | Standard Deviation 45 |
| Standard Message Decision Rules | Physical Activity Self-monitoring Adherence | 133.9 days | Standard Deviation 45.9 |
| Adaptive Message Decision Rules | Physical Activity Self-monitoring Adherence | 133.6 days | Standard Deviation 45.8 |
| No Message Choice | Physical Activity Self-monitoring Adherence | 131.4 days | Standard Deviation 48.2 |
| Message Choice | Physical Activity Self-monitoring Adherence | 136.2 days | Standard Deviation 43.2 |
Secondary
Relatedness Score
Relatedness at 3 and 6 months as measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include The messages demonstrate caring about me as a person and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages.
Time frame: 3 months, 6 months
Population: Participants who completed the relatedness subscale at 3 months; participants who completed the relatedness subscale at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Relatedness Score | Relatedness at 3 Months | 4.91 score on a scale | Standard Deviation 1.47 |
| Standard Diet Monitoring | Relatedness Score | Relatedness at 6 Months | 4.79 score on a scale | Standard Deviation 1.57 |
| Simplified Diet Monitoring | Relatedness Score | Relatedness at 3 Months | 4.95 score on a scale | Standard Deviation 1.4 |
| Simplified Diet Monitoring | Relatedness Score | Relatedness at 6 Months | 4.90 score on a scale | Standard Deviation 1.51 |
| Weekly Adaptive Activity Goals | Relatedness Score | Relatedness at 3 Months | 4.86 score on a scale | Standard Deviation 1.42 |
| Weekly Adaptive Activity Goals | Relatedness Score | Relatedness at 6 Months | 4.83 score on a scale | Standard Deviation 1.5 |
| Daily Adaptive Activity Goals | Relatedness Score | Relatedness at 3 Months | 5.01 score on a scale | Standard Deviation 1.45 |
| Daily Adaptive Activity Goals | Relatedness Score | Relatedness at 6 Months | 4.85 score on a scale | Standard Deviation 1.58 |
| Fixed Message Decision Points | Relatedness Score | Relatedness at 6 Months | 4.91 score on a scale | Standard Deviation 1.52 |
| Fixed Message Decision Points | Relatedness Score | Relatedness at 3 Months | 4.99 score on a scale | Standard Deviation 1.42 |
| Adaptive Message Decision Points | Relatedness Score | Relatedness at 6 Months | 4.77 score on a scale | Standard Deviation 1.56 |
| Adaptive Message Decision Points | Relatedness Score | Relatedness at 3 Months | 4.88 score on a scale | Standard Deviation 1.45 |
| Standard Message Decision Rules | Relatedness Score | Relatedness at 6 Months | 4.86 score on a scale | Standard Deviation 1.53 |
| Standard Message Decision Rules | Relatedness Score | Relatedness at 3 Months | 4.91 score on a scale | Standard Deviation 1.4 |
| Adaptive Message Decision Rules | Relatedness Score | Relatedness at 3 Months | 4.96 score on a scale | Standard Deviation 1.48 |
| Adaptive Message Decision Rules | Relatedness Score | Relatedness at 6 Months | 4.83 score on a scale | Standard Deviation 1.55 |
| No Message Choice | Relatedness Score | Relatedness at 3 Months | 5.04 score on a scale | Standard Deviation 1.43 |
| No Message Choice | Relatedness Score | Relatedness at 6 Months | 4.93 score on a scale | Standard Deviation 1.52 |
| Message Choice | Relatedness Score | Relatedness at 3 Months | 4.83 score on a scale | Standard Deviation 1.44 |
| Message Choice | Relatedness Score | Relatedness at 6 Months | 4.75 score on a scale | Standard Deviation 1.55 |
Secondary
Sedentary Behavior Score
Change in sedentary behavior from baseline to 3 and 6 months as measured using the 12- item Sedentary Behavior Questionnaire which asks respondents to indicate the number of hours they spend on a typical weekday and a typical weekend day doing each of six activities. The scale ranges from none to 6 or more hours for each item. Higher values on the Sedentary Behavior Questionnaire indicate greater amount of time spent in sedentary behavior. Range is 0 to 24 hours and outcome is change in minutes per day.
Time frame: Baseline, 3 months, 6 months
Population: Participants who completed the Sedentary Behavior Questionnaire at 3 months; participants who completed the Sedentary Behavior Questionnaire at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Sedentary Behavior Score | Baseline to 6 Months | -22.7 minutes/day | Standard Deviation 218.9 |
| Standard Diet Monitoring | Sedentary Behavior Score | Baseline to 3 Months | -35.3 minutes/day | Standard Deviation 207.6 |
| Simplified Diet Monitoring | Sedentary Behavior Score | Baseline to 3 Months | -36.1 minutes/day | Standard Deviation 223.4 |
| Simplified Diet Monitoring | Sedentary Behavior Score | Baseline to 6 Months | -34.1 minutes/day | Standard Deviation 227 |
| Weekly Adaptive Activity Goals | Sedentary Behavior Score | Baseline to 3 Months | -33.9 minutes/day | Standard Deviation 194 |
| Weekly Adaptive Activity Goals | Sedentary Behavior Score | Baseline to 6 Months | -11.8 minutes/day | Standard Deviation 223.7 |
| Daily Adaptive Activity Goals | Sedentary Behavior Score | Baseline to 6 Months | -45.7 minutes/day | Standard Deviation 221.1 |
| Daily Adaptive Activity Goals | Sedentary Behavior Score | Baseline to 3 Months | -37.6 minutes/day | Standard Deviation 236.2 |
| Fixed Message Decision Points | Sedentary Behavior Score | Baseline to 3 Months | -41.1 minutes/day | Standard Deviation 200.9 |
| Fixed Message Decision Points | Sedentary Behavior Score | Baseline to 6 Months | -39.9 minutes/day | Standard Deviation 223.7 |
| Adaptive Message Decision Points | Sedentary Behavior Score | Baseline to 3 Months | -30.3 minutes/day | Standard Deviation 229.5 |
| Adaptive Message Decision Points | Sedentary Behavior Score | Baseline to 6 Months | -16.6 minutes/day | Standard Deviation 221.8 |
| Standard Message Decision Rules | Sedentary Behavior Score | Baseline to 3 Months | -40.9 minutes/day | Standard Deviation 217.3 |
| Standard Message Decision Rules | Sedentary Behavior Score | Baseline to 6 Months | -28.3 minutes/day | Standard Deviation 230.1 |
| Adaptive Message Decision Rules | Sedentary Behavior Score | Baseline to 3 Months | -30.5 minutes/day | Standard Deviation 213.9 |
| Adaptive Message Decision Rules | Sedentary Behavior Score | Baseline to 6 Months | -28.6 minutes/day | Standard Deviation 215.9 |
| No Message Choice | Sedentary Behavior Score | Baseline to 6 Months | -28.3 minutes/day | Standard Deviation 236.8 |
| No Message Choice | Sedentary Behavior Score | Baseline to 3 Months | -34.1 minutes/day | Standard Deviation 222.9 |
| Message Choice | Sedentary Behavior Score | Baseline to 3 Months | -37.4 minutes/day | Standard Deviation 208.1 |
| Message Choice | Sedentary Behavior Score | Baseline to 6 Months | -28.5 minutes/day | Standard Deviation 208.1 |
Secondary
Treatment Self-Regulation Score
Change in treatment self-regulation from baseline to 3 and 6 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: Because I feel that I want to take responsibility for my own health answered on a scale of 1 (not at all true) to 7 (very true). Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for diet at 3 and 6 months, and changes in autonomous and controlled motivation for activity at 3 and 6 months.
Time frame: Baseline, 3 months, 6 months
Population: Participants who completed the TSRQ at 3 months; participants who completed the TSRQ at 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.16 score on a scale | Standard Deviation 1.1 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.17 score on a scale | Standard Deviation 1.06 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.19 score on a scale | Standard Deviation 0.93 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.17 score on a scale | Standard Deviation 1.17 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.07 score on a scale | Standard Deviation 1.04 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | -0.01 score on a scale | Standard Deviation 1.07 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.07 score on a scale | Standard Deviation 1.14 |
| Standard Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.06 score on a scale | Standard Deviation 1.11 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.03 score on a scale | Standard Deviation 1.02 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.06 score on a scale | Standard Deviation 0.94 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.17 score on a scale | Standard Deviation 1.11 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.06 score on a scale | Standard Deviation 1.2 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.23 score on a scale | Standard Deviation 0.87 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.18 score on a scale | Standard Deviation 0.98 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.14 score on a scale | Standard Deviation 1.03 |
| Simplified Diet Monitoring | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.07 score on a scale | Standard Deviation 1.16 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.12 score on a scale | Standard Deviation 0.97 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.15 score on a scale | Standard Deviation 1.1 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.17 score on a scale | Standard Deviation 1.04 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.01 score on a scale | Standard Deviation 0.91 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.16 score on a scale | Standard Deviation 1.16 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.15 score on a scale | Standard Deviation 1.17 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.07 score on a scale | Standard Deviation 0.94 |
| Weekly Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.16 score on a scale | Standard Deviation 0.87 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.04 score on a scale | Standard Deviation 1.13 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.06 score on a scale | Standard Deviation 1.04 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.23 score on a scale | Standard Deviation 1.07 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.08 score on a scale | Standard Deviation 1.13 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.25 score on a scale | Standard Deviation 0.92 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.02 score on a scale | Standard Deviation 1.17 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.08 score on a scale | Standard Deviation 1.17 |
| Daily Adaptive Activity Goals | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.06 score on a scale | Standard Deviation 1.13 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.16 score on a scale | Standard Deviation 1.07 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.14 score on a scale | Standard Deviation 1 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.09 score on a scale | Standard Deviation 1.03 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.19 score on a scale | Standard Deviation 0.85 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.07 score on a scale | Standard Deviation 1.15 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.12 score on a scale | Standard Deviation 1.16 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.02 score on a scale | Standard Deviation 0.96 |
| Fixed Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.08 score on a scale | Standard Deviation 1 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.12 score on a scale | Standard Deviation 1.17 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.07 score on a scale | Standard Deviation 1.15 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.14 score on a scale | Standard Deviation 1.15 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | -0.06 score on a scale | Standard Deviation 1.09 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.11 score on a scale | Standard Deviation 1.02 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.22 score on a scale | Standard Deviation 0.94 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.21 score on a scale | Standard Deviation 1.05 |
| Adaptive Message Decision Points | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.12 score on a scale | Standard Deviation 1.14 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.10 score on a scale | Standard Deviation 1.08 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.06 score on a scale | Standard Deviation 1.03 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.09 score on a scale | Standard Deviation 1.06 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.21 score on a scale | Standard Deviation 0.9 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.20 score on a scale | Standard Deviation 1.08 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.17 score on a scale | Standard Deviation 1.11 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.02 score on a scale | Standard Deviation 0.99 |
| Standard Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.00 score on a scale | Standard Deviation 1.12 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.20 score on a scale | Standard Deviation 0.9 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.15 score on a scale | Standard Deviation 0.97 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.13 score on a scale | Standard Deviation 1.24 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.07 score on a scale | Standard Deviation 1.22 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.12 score on a scale | Standard Deviation 0.99 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.14 score on a scale | Standard Deviation 1.14 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.03 score on a scale | Standard Deviation 0.97 |
| Adaptive Message Decision Rules | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.16 score on a scale | Standard Deviation 1.14 |
| No Message Choice | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.08 score on a scale | Standard Deviation 1.08 |
| No Message Choice | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.03 score on a scale | Standard Deviation 1.15 |
| No Message Choice | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | 0.04 score on a scale | Standard Deviation 1.09 |
| No Message Choice | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.02 score on a scale | Standard Deviation 1.17 |
| No Message Choice | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.18 score on a scale | Standard Deviation 0.89 |
| No Message Choice | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.17 score on a scale | Standard Deviation 1.02 |
| No Message Choice | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.03 score on a scale | Standard Deviation 0.97 |
| No Message Choice | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.06 score on a scale | Standard Deviation 1.1 |
| Message Choice | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 6 months | 0.21 score on a scale | Standard Deviation 1.17 |
| Message Choice | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 3 months | -0.10 score on a scale | Standard Deviation 1.01 |
| Message Choice | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 3 months | 0.13 score on a scale | Standard Deviation 1.09 |
| Message Choice | Treatment Self-Regulation Score | Controlled motivation for physical activity baseline to 6 months | 0.17 score on a scale | Standard Deviation 1.12 |
| Message Choice | Treatment Self-Regulation Score | Autonomous motivation for physical activity baseline to 6 months | -0.02 score on a scale | Standard Deviation 1 |
| Message Choice | Treatment Self-Regulation Score | Controlled motivation for diet baseline to 3 months | 0.20 score on a scale | Standard Deviation 1.12 |
| Message Choice | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 6 months | -0.18 score on a scale | Standard Deviation 1.03 |
| Message Choice | Treatment Self-Regulation Score | Autonomous motivation for diet baseline to 3 months | -0.23 score on a scale | Standard Deviation 0.91 |
Secondary
Weighing Adherence
Mean number of days of self-weighing over the 6 month period.
Time frame: Baseline to 6 months (daily)
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Diet Monitoring | Weighing Adherence | 90.2 days | Standard Deviation 51.4 |
| Simplified Diet Monitoring | Weighing Adherence | 87.4 days | Standard Deviation 49.6 |
| Weekly Adaptive Activity Goals | Weighing Adherence | 87.5 days | Standard Deviation 50.9 |
| Daily Adaptive Activity Goals | Weighing Adherence | 90.0 days | Standard Deviation 50.1 |
| Fixed Message Decision Points | Weighing Adherence | 87.9 days | Standard Deviation 50.6 |
| Adaptive Message Decision Points | Weighing Adherence | 89.6 days | Standard Deviation 50.5 |
| Standard Message Decision Rules | Weighing Adherence | 90.5 days | Standard Deviation 51.2 |
| Adaptive Message Decision Rules | Weighing Adherence | 87.0 days | Standard Deviation 49.8 |
| No Message Choice | Weighing Adherence | 88.6 days | Standard Deviation 50.8 |
| Message Choice | Weighing Adherence | 89.0 days | Standard Deviation 50.3 |
Secondary
Weight (kg)
Estimated mean weight change in kg from baseline to 3 months for each of the two levels of each component (factor) obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Diet Monitoring | Weight (kg) | -2.54 kg |
| Simplified Diet Monitoring | Weight (kg) | -2.30 kg |
| Weekly Adaptive Activity Goals | Weight (kg) | -2.22 kg |
| Daily Adaptive Activity Goals | Weight (kg) | -2.63 kg |
| Fixed Message Decision Points | Weight (kg) | -2.69 kg |
| Adaptive Message Decision Points | Weight (kg) | -2.16 kg |
| Standard Message Decision Rules | Weight (kg) | -2.58 kg |
| Adaptive Message Decision Rules | Weight (kg) | -2.26 kg |
| No Message Choice | Weight (kg) | -2.27 kg |
| Message Choice | Weight (kg) | -2.58 kg |
Comparison: ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).p-value: 0.4395% CI: [-0.36, 0.84]Mixed Models Analysis
Comparison: ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).p-value: 0.1795% CI: [-1.01, 0.18]Mixed Models Analysis
Comparison: ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).p-value: 0.0895% CI: [-0.06, 1.13]Mixed Models Analysis
Comparison: ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).p-value: 0.5895% CI: [-0.28, 0.91]Mixed Models Analysis
Comparison: ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).p-value: 0.5595% CI: [-0.91, 0.28]Mixed Models Analysis