Physical Activity, Neoplasms, Cancer
Conditions
Brief summary
The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.
Detailed description
There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.
Interventions
BEHAVIORALCore Intervention
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
BEHAVIORALSimplified Dietary Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
BEHAVIORALSimplified Dietary Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
BEHAVIORALNutrition Goals (Yes)
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
BEHAVIORALNutrition Goals (No)
Participant will not be assigned a personalized weekly nutrition goal.
BEHAVIORALSupportive Text Messages (Yes)
Participant will receive up to 5 supportive text-messages from the study staff per week.
BEHAVIORALSupportive Text Messages (No)
Participant will not receive supportive text-messages.
BEHAVIORALLesson Delivery (Once)
All behavioral lessons will be made available to participant simultaneously.
BEHAVIORALLesson Delivery (Weekly)
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Current age 18-39 years at the time of consent * Diagnosed with invasive cancer malignancy between the ages of 15-39 years * Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers * Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving maintenance therapy to prevent recurrences * No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions * Not currently meeting guideline recommendations of 150 minutes/week moderate to vigorous physical activity (self-report) and guideline recommendations for fruit and vegetable consumption (self-report) * Have the ability to read, write and speak English * Have access to the Internet on at least a weekly basis * Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail) * Have smartphone with internet access and text messaging plan * Be willing to be randomized to any condition
Exclusion criteria
* History of heart attack or stroke within past 6 months * Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider * Health problems which preclude ability to walk for physical activity * Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency * Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa) * Plans for major surgery (e.g., breast reconstruction) during the study time frame * Current participation in another physical activity or weight control program * Currently using prescription weight loss medications * Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months * Currently exercising \> 150 minutes/week of moderate-to-vigorous intensity physical activity * Currently consuming \> 5 servings of fruits and vegetables/day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual Rate | End of study enrollment period (7 months). | Number of participants who agreed to participate divided by the number of months of recruitment. |
| Participation Rate | End of study enrollment period (7 months). | Percentage of consented participants who were randomized. |
| Retention Rate | 3 months | Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate-to-vigorous Physical Activity (Objective) | Baseline, 3 months. | Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. |
| Moderate-to-vigorous Physical Activity (Self-report) | Baseline, 3 months. | Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the 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. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum. |
| Dietary Intake: Healthy Eating Index (HEI) | Baseline, 3 months | Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance. |
| Weight (kg) | Baseline, 3 months | Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight). |
| Fried Physical Frailty : FRAIL Index | Baseline, 3 Months | The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as Frailty Status; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed. |
| Acceptability: How Satisfied Are You Overall With the Program You Received? | 3 months | 1-item measure; a benchmark of 80% of participants answering somewhat or very satisfied would indicate acceptability |
| Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | Baseline, 3 months | Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, In the past 7 days, how would you rate your pain on average? Scored 0-10 from no pain to the worst imaginable pain. |
| Competence for Exercise and Nutrition | Baseline, 3 months | Changes in perceived competence from baseline to 3 months as measured using 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. |
| Self-efficacy for Exercise and Nutrition | Baseline, 3 months | Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months. |
| Self-Regulation for Exercise and Nutrition | Baseline, 3 months | Changes in self-regulation from baseline to 3 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). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. 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. 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 exercise and diet at 3 months. |
| Autonomy Support | Baseline, 3 months | Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point 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 autonomy support in a virtual setting. |
| Health-related Quality of Life: AYA PROMIS PRO Core Battery | Baseline, 3 months | Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. |
| Adherence to Physical Activity Monitoring. | Through study completion, 3 months. | Number of days physical activity tracked, as measured by Fitbit. |
| Adherence to Diet Self-monitoring | Through study completion, 3 months. | Number of days of complete dietary tracking. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from October 2023 and April 2024; remote recruitment across the continental United States. 220 individuals completed the online screening survey; 83 were initially eligible; out of those, 11 completed informed consent but were ineligible due to no longer being interested in participating or incomplete baseline measurement procedures, and 72 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 16 conditions.
Participants by arm
| Arm | Count |
|---|---|
| Condition 1 Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons | 4 |
| Condition 2 Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons | 5 |
| Condition 3 Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons | 4 |
| Condition 4 Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons | 4 |
| Condition 5 Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons | 3 |
| Condition 6 Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons | 4 |
| Condition 7 Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons | 6 |
| Condition 8 Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons | 4 |
| Condition 9 Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons | 2 |
| Condition 10 Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons | 5 |
| Condition 11 Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons | 5 |
| Condition 12 Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons | 5 |
| Condition 13 Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons | 6 |
| Condition 14 Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons | 7 |
| Condition 15 Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons | 4 |
| Condition 16 Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons | 4 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Condition 16 | Condition 15 | Condition 14 | Condition 13 | Condition 12 | Condition 11 | Condition 10 | Condition 1 | Condition 9 | Condition 8 | Condition 7 | Condition 6 | Condition 5 | Condition 4 | Condition 3 | Condition 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 5.2 | 33.5 years STANDARD_DEVIATION 3.45 | 29.4 years STANDARD_DEVIATION 5.56 | 36.6 years STANDARD_DEVIATION 2.82 | 32.2 years STANDARD_DEVIATION 5.48 | 31.8 years STANDARD_DEVIATION 5.34 | 31.6 years STANDARD_DEVIATION 7.06 | 35.2 years STANDARD_DEVIATION 4.03 | 34.2 years STANDARD_DEVIATION 1.81 | 34.2 years STANDARD_DEVIATION 0.92 | 34.1 years STANDARD_DEVIATION 5.77 | 34.8 years STANDARD_DEVIATION 3.14 | 34.5 years STANDARD_DEVIATION 8.07 | 38.6 years STANDARD_DEVIATION 1.18 | 31.2 years STANDARD_DEVIATION 8.13 | 29.2 years STANDARD_DEVIATION 7.36 | 34.1 years STANDARD_DEVIATION 6.15 |
| Body Mass Index (BMI) | 28.46 kg/m^2 STANDARD_DEVIATION 7.92 | 26.31 kg/m^2 STANDARD_DEVIATION 6.11 | 26.82 kg/m^2 STANDARD_DEVIATION 7.47 | 28.13 kg/m^2 STANDARD_DEVIATION 4.06 | 30.24 kg/m^2 STANDARD_DEVIATION 4.22 | 27.24 kg/m^2 STANDARD_DEVIATION 6.52 | 30.49 kg/m^2 STANDARD_DEVIATION 8.37 | 25.20 kg/m^2 STANDARD_DEVIATION 6.67 | 26.04 kg/m^2 STANDARD_DEVIATION 6.88 | 32.33 kg/m^2 STANDARD_DEVIATION 15.22 | 34.84 kg/m^2 STANDARD_DEVIATION 21.55 | 33.01 kg/m^2 STANDARD_DEVIATION 8.74 | 29.72 kg/m^2 STANDARD_DEVIATION 2.57 | 26.83 kg/m^2 STANDARD_DEVIATION 1.9 | 26.22 kg/m^2 STANDARD_DEVIATION 6.37 | 21.66 kg/m^2 STANDARD_DEVIATION 2.78 | 29.30 kg/m^2 STANDARD_DEVIATION 9.29 |
| Diet | 52.74 Points STANDARD_DEVIATION 12.58 | 48.30 Points STANDARD_DEVIATION 15.05 | 50.02 Points STANDARD_DEVIATION 7.69 | 53.34 Points STANDARD_DEVIATION 9.96 | 53.97 Points STANDARD_DEVIATION 11.88 | 54.51 Points STANDARD_DEVIATION 14.79 | 49.33 Points STANDARD_DEVIATION 12.88 | 57.53 Points STANDARD_DEVIATION 9.58 | 46.55 Points STANDARD_DEVIATION 15.21 | 66.39 Points STANDARD_DEVIATION 14.12 | 54.26 Points STANDARD_DEVIATION 12.95 | 51.51 Points STANDARD_DEVIATION 14.45 | 46.93 Points STANDARD_DEVIATION 10.16 | 64.93 Points STANDARD_DEVIATION 3.81 | 57.93 Points STANDARD_DEVIATION 12.33 | 39.52 Points STANDARD_DEVIATION 9.13 | 56.52 Points STANDARD_DEVIATION 18.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 4 Participants | 3 Participants | 7 Participants | 5 Participants | 5 Participants | 5 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 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 |
| Physical Activity (MVPA) | 181.86 min/wk STANDARD_DEVIATION 161.93 | 221.00 min/wk STANDARD_DEVIATION 27.29 | 177.75 min/wk STANDARD_DEVIATION 101.74 | 203.14 min/wk STANDARD_DEVIATION 188.81 | 122.50 min/wk STANDARD_DEVIATION 104.09 | 152.00 min/wk STANDARD_DEVIATION 106.84 | 124.00 min/wk STANDARD_DEVIATION 200.22 | 280.00 min/wk STANDARD_DEVIATION 195.54 | 173.25 min/wk STANDARD_DEVIATION 37.69 | 50.50 min/wk STANDARD_DEVIATION 2.12 | 200.25 min/wk STANDARD_DEVIATION 150.93 | 250.00 min/wk STANDARD_DEVIATION 218.85 | 184.00 min/wk STANDARD_DEVIATION 258.98 | 395.67 min/wk STANDARD_DEVIATION 143.83 | 91.75 min/wk STANDARD_DEVIATION 52 | 73.25 min/wk STANDARD_DEVIATION 63.89 | 176.80 min/wk STANDARD_DEVIATION 247.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 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) Asian | 2 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 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 | 1 Participants | 0 Participants | 0 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 |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 60 Participants | 4 Participants | 3 Participants | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Region of Enrollment United States | 72 Participants | 4 Participants | 4 Participants | 7 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 2 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 5 Participants |
| Sex/Gender, Customized Sex Female | 62 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 4 Participants |
| Sex/Gender, Customized Sex Male | 10 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Weight (lb) | 174.31 pounds STANDARD_DEVIATION 40.51 | 173.75 pounds STANDARD_DEVIATION 28.48 | 156.25 pounds STANDARD_DEVIATION 39.02 | 180.14 pounds STANDARD_DEVIATION 31.39 | 183.17 pounds STANDARD_DEVIATION 26.07 | 182.60 pounds STANDARD_DEVIATION 63.87 | 175.80 pounds STANDARD_DEVIATION 50.31 | 169.60 pounds STANDARD_DEVIATION 48.28 | 163.50 pounds STANDARD_DEVIATION 24.61 | 203.50 pounds STANDARD_DEVIATION 72.83 | 182.00 pounds STANDARD_DEVIATION 85.12 | 188.33 pounds STANDARD_DEVIATION 26.27 | 174.00 pounds STANDARD_DEVIATION 8.04 | 167.33 pounds STANDARD_DEVIATION 8.96 | 168.00 pounds STANDARD_DEVIATION 36.12 | 136.25 pounds STANDARD_DEVIATION 18.08 | 179.20 pounds STANDARD_DEVIATION 60.4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 6 | 0 / 4 | 0 / 2 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 7 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 3 / 4 | 4 / 5 | 0 / 4 | 3 / 4 | 2 / 3 | 1 / 4 | 1 / 6 | 2 / 4 | 1 / 2 | 3 / 5 | 3 / 5 | 3 / 5 | 3 / 6 | 4 / 7 | 1 / 4 | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 1 / 4 | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 6 | 0 / 4 | 0 / 2 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 7 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Accrual Rate
Number of participants who agreed to participate divided by the number of months of recruitment.
Time frame: End of study enrollment period (7 months).
Population: Because this measure pertains to the study as a whole, the number of participants is not reported by arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Recruited | Accrual Rate | 12 Participants per month |
Primary
Participation Rate
Percentage of consented participants who were randomized.
Time frame: End of study enrollment period (7 months).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited | Participation Rate | 72 Participants |
Primary
Retention Rate
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited | Retention Rate | 4 Participants |
| Condition 2 | Retention Rate | 4 Participants |
| Condition 3 | Retention Rate | 3 Participants |
| Condition 4 | Retention Rate | 2 Participants |
| Condition 5 | Retention Rate | 3 Participants |
| Condition 6 | Retention Rate | 4 Participants |
| Condition 7 | Retention Rate | 6 Participants |
| Condition 8 | Retention Rate | 4 Participants |
| Condition 9 | Retention Rate | 1 Participants |
| Condition 10 | Retention Rate | 3 Participants |
| Condition 11 | Retention Rate | 3 Participants |
| Condition 12 | Retention Rate | 4 Participants |
| Condition 13 | Retention Rate | 6 Participants |
| Condition 14 | Retention Rate | 7 Participants |
| Condition 15 | Retention Rate | 4 Participants |
| Condition 16 | Retention Rate | 3 Participants |
Secondary
Acceptability: How Satisfied Are You Overall With the Program You Received?
1-item measure; a benchmark of 80% of participants answering somewhat or very satisfied would indicate acceptability
Time frame: 3 months
Population: Among completers of the 12-week questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited | Acceptability: How Satisfied Are You Overall With the Program You Received? | 24 Participants |
| Condition 2 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 27 Participants |
| Condition 3 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 20 Participants |
| Condition 4 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 31 Participants |
| Condition 5 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 26 Participants |
| Condition 6 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 25 Participants |
| Condition 7 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 25 Participants |
| Condition 8 | Acceptability: How Satisfied Are You Overall With the Program You Received? | 26 Participants |
Secondary
Adherence to Diet Self-monitoring
Number of days of complete dietary tracking.
Time frame: Through study completion, 3 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Recruited | Adherence to Diet Self-monitoring | 43 Days |
| Condition 2 | Adherence to Diet Self-monitoring | 49.5 Days |
| Condition 3 | Adherence to Diet Self-monitoring | 39.5 Days |
| Condition 4 | Adherence to Diet Self-monitoring | 52 Days |
| Condition 5 | Adherence to Diet Self-monitoring | 52 Days |
| Condition 6 | Adherence to Diet Self-monitoring | 35 Days |
| Condition 7 | Adherence to Diet Self-monitoring | 48.5 Days |
| Condition 8 | Adherence to Diet Self-monitoring | 44.5 Days |
Secondary
Adherence to Physical Activity Monitoring.
Number of days physical activity tracked, as measured by Fitbit.
Time frame: Through study completion, 3 months.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants Recruited | Adherence to Physical Activity Monitoring. | 81.5 Days | Inter-Quartile Range 21 |
| Condition 2 | Adherence to Physical Activity Monitoring. | 70.8 Days | Inter-Quartile Range 21 |
| Condition 3 | Adherence to Physical Activity Monitoring. | 79 Days | Inter-Quartile Range 25.1 |
| Condition 4 | Adherence to Physical Activity Monitoring. | 83 Days | — |
| Condition 5 | Adherence to Physical Activity Monitoring. | 83 Days | — |
| Condition 6 | Adherence to Physical Activity Monitoring. | 79 Days | — |
| Condition 7 | Adherence to Physical Activity Monitoring. | 81.5 Days | — |
| Condition 8 | Adherence to Physical Activity Monitoring. | 83 Days | — |
Secondary
Autonomy Support
Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point 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 autonomy support in a virtual setting.
Time frame: Baseline, 3 months
Population: Participants who completed the Virtual Care Climate Questionnaire (VCCQ) at 3 months.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Participants Recruited | Autonomy Support | 4.98 Score on scale | Standard Deviation 1.06 |
| Condition 2 | Autonomy Support | 4.84 Score on scale | Standard Deviation 1.13 |
| Condition 3 | Autonomy Support | 4.59 Score on scale | Standard Deviation 0.89 |
| Condition 4 | Autonomy Support | 5.12 Score on scale | Standard Deviation 1.16 |
| Condition 5 | Autonomy Support | 4.97 Score on scale | Standard Deviation 1.24 |
| Condition 6 | Autonomy Support | 4.85 Score on scale | Standard Deviation 0.92 |
| Condition 7 | Autonomy Support | 5.07 Score on scale | Standard Deviation 1.18 |
| Condition 8 | Autonomy Support | 4.75 Score on scale | Standard Deviation 0.98 |
| Condition 9 | Autonomy Support | 4.91 Score on scale | Standard Deviation 1.09 |
Secondary
Competence for Exercise and Nutrition
Changes in perceived competence from baseline to 3 months as measured using 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.
Time frame: Baseline, 3 months
Population: Participants who completed the Perceived Competence Scales for Nutrition and Diet at 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Recruited | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 1.13 Score on scale | Standard Deviation 4.49 |
| Participants Recruited | Competence for Exercise and Nutrition | Perceived Competence for Exercise | 0.6 Score on scale | Standard Deviation 6.15 |
| Condition 2 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | -1.61 Score on scale | Standard Deviation 4.09 |
| Condition 2 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | -0.03 Score on scale | Standard Deviation 2.98 |
| Condition 3 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 0.54 Score on scale | Standard Deviation 4.53 |
| Condition 3 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | -1.38 Score on scale | Standard Deviation 5.52 |
| Condition 4 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | 0.027 Score on scale | Standard Deviation 5.12 |
| Condition 4 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 0.54 Score on scale | Standard Deviation 3.34 |
| Condition 5 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | -1.28 Score on scale | Standard Deviation 5.13 |
| Condition 5 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 0.28 Score on scale | Standard Deviation 4.11 |
| Condition 6 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 0.83 Score on scale | Standard Deviation 3.51 |
| Condition 6 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | 0.31 Score on scale | Standard Deviation 5.41 |
| Condition 7 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | 0.9 Score on scale | Standard Deviation 5.51 |
| Condition 7 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 1.53 Score on scale | Standard Deviation 3.14 |
| Condition 8 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | -1.90 Score on scale | Standard Deviation 4.74 |
| Condition 8 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | -0.42 Score on scale | Standard Deviation 4.2 |
| Condition 9 | Competence for Exercise and Nutrition | Perceived Competence for Nutrition | 0.54 Score on scale | Standard Deviation 3.81 |
| Condition 9 | Competence for Exercise and Nutrition | Perceived Competence for Exercise | -0.53 Score on scale | Standard Deviation 5.28 |
Secondary
Dietary Intake: Healthy Eating Index (HEI)
Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Time frame: Baseline, 3 months
Population: ITT: all randomized participants using all available ASA24 data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Recruited | Dietary Intake: Healthy Eating Index (HEI) | 4.66 Points |
| Condition 2 | Dietary Intake: Healthy Eating Index (HEI) | 0.32 Points |
| Condition 3 | Dietary Intake: Healthy Eating Index (HEI) | 4.65 Points |
| Condition 4 | Dietary Intake: Healthy Eating Index (HEI) | 0.32 Points |
| Condition 5 | Dietary Intake: Healthy Eating Index (HEI) | 1.85 Points |
| Condition 6 | Dietary Intake: Healthy Eating Index (HEI) | 3.13 Points |
| Condition 7 | Dietary Intake: Healthy Eating Index (HEI) | 3.38 Points |
| Condition 8 | Dietary Intake: Healthy Eating Index (HEI) | 1.59 Points |
Comparison: ITT analysis using linear mixed models comparing HEI score change over time (from baseline to 3 months). We fit a linear mixed model that included a random effect for participant and predictors (fixed effects) included time (baseline vs. follow-up) and all 4 factors.p-value: 0.10995% CI: [-0.56, 5.54]Mixed Models Analysis
Comparison: ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on HEI score change over time (from baseline to 3 months).p-value: 0.7195% CI: [-7.42, 5.08]Mixed Models Analysis
Comparison: ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on HEI score change over time (from baseline to 3 months).p-value: 0.8995% CI: [-5.82, 6.69]Mixed Models Analysis
Comparison: ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on HEI score change over time (from baseline to 3 months).p-value: 0.2595% CI: [-2.61, 9.93]Mixed Models Analysis
Comparison: ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on HEI score change over time (from baseline to 3 months).p-value: 0.5795% CI: [-8.11, 4.45]Mixed Models Analysis
Secondary
Fried Physical Frailty : FRAIL Index
The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as Frailty Status; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.
Time frame: Baseline, 3 Months
Population: All randomized were characterized by Frailty Status (Robust, Prefrail, Frail) at baseline and 3-months. At 3 months, NA = insufficient data for classification based on missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Recruited | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 0 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 0 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 34 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 29 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 1 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Participants Recruited | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 4 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 25 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 3 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 6 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 34 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 1 Participants |
| Condition 2 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 7 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 22 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 10 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 2 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 2 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 32 Participants |
| Condition 3 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 0 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 1 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 1 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 36 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 1 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 32 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 5 Participants |
| Condition 4 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 1 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 35 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 4 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 27 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 5 Participants |
| Condition 5 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 0 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 7 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 1 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 2 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 33 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 2 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 27 Participants |
| Condition 6 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 2 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 0 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 27 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 3 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 4 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
| Condition 7 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 32 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | NA | 7 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Prefrail | 4 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Robust | 27 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | NA | 0 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Frail | 1 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Prefrail | 1 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | Baseline Frailty Status | Robust | 36 Participants |
| Condition 8 | Fried Physical Frailty : FRAIL Index | 3-Month Frailty Status | Frail | 0 Participants |
Secondary
Health-related Quality of Life: AYA PROMIS PRO Core Battery
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.
Time frame: Baseline, 3 months
Population: Participants who completed the PROMIS measures at 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 3.37 T-score | Standard Deviation 6.12 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 2.86 T-score | Standard Deviation 8.67 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.50 T-score | Standard Deviation 7.53 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | 1.68 T-score | Standard Deviation 9.19 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 1.08 T-score | Standard Deviation 5.29 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -4.26 T-score | Standard Deviation 9.64 |
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -2.06 T-score | Standard Deviation 6.22 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 0.60 T-score | Standard Deviation 6.79 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | -1.85 T-score | Standard Deviation 5.83 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 1.48 T-score | Standard Deviation 6.3 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.14 T-score | Standard Deviation 7.95 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -0.003 T-score | Standard Deviation 5.57 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -0.65 T-score | Standard Deviation 9.08 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 2.65 T-score | Standard Deviation 6.19 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 3.30 T-score | Standard Deviation 7.56 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -1.33 T-score | Standard Deviation 6.05 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | -0.86 T-score | Standard Deviation 6.28 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 3.30 T-score | Standard Deviation 5.45 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -0.83 T-score | Standard Deviation 9.24 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -3.28 T-score | Standard Deviation 7.34 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | 1.72 T-score | Standard Deviation 9.87 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -1.87 T-score | Standard Deviation 10.7 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 1.41 T-score | Standard Deviation 7.51 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 1.94 T-score | Standard Deviation 5.71 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -0.81 T-score | Standard Deviation 5.94 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | -1.3 T-score | Standard Deviation 5.97 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 2.81 T-score | Standard Deviation 6.57 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.63 T-score | Standard Deviation 6.51 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 0.25 T-score | Standard Deviation 4.78 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | 1.75 T-score | Standard Deviation 9.01 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.76 T-score | Standard Deviation 6.28 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -3.45 T-score | Standard Deviation 9.67 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 3.16 T-score | Standard Deviation 6.61 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -2.42 T-score | Standard Deviation 6.67 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 1.18 T-score | Standard Deviation 7.1 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -1.29 T-score | Standard Deviation 9.26 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | 0.54 T-score | Standard Deviation 4.64 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | -2.17 T-score | Standard Deviation 5.68 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 2.83 T-score | Standard Deviation 5.62 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 1.49 T-score | Standard Deviation 7.23 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 3.24 T-score | Standard Deviation 7.95 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -0.83 T-score | Standard Deviation 9.07 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 1.85 T-score | Standard Deviation 4.92 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 1.55 T-score | Standard Deviation 5.14 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -0.08 T-score | Standard Deviation 5.9 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 2.81 T-score | Standard Deviation 9.03 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -2.64 T-score | Standard Deviation 10.8 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | -1.70 T-score | Standard Deviation 7.71 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.41 T-score | Standard Deviation 8.89 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 0.15 T-score | Standard Deviation 6.83 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -2.22 T-score | Standard Deviation 8.14 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 4.12 T-score | Standard Deviation 6.98 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.23 T-score | Standard Deviation 6.45 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 1.53 T-score | Standard Deviation 5.79 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -1.91 T-score | Standard Deviation 5.93 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | 1.42 T-score | Standard Deviation 7.71 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Depressive Symptoms (PROMIS v1.0-Depression Short Form 4a) | -0.11 T-score | Standard Deviation 7.81 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Emotional Support (PROMIS v2.0 Emotional Support Short Form 4a) | -1.01 T-score | Standard Deviation 5.94 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Cognitive Function (PROMIS v2.0 Cognitive Function Short Form 4a) | 2.16 T-score | Standard Deviation 7.52 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Anxiety (PROMIS v1.0-Emotional Distress Anxiety Short Form 4a) | -1.32 T-score | Standard Deviation 7.68 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Pain Interference (PROMIS v1.1 Pain Interference Short Form 4a) | 3.00 T-score | Standard Deviation 6.11 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Fatigue (PROMIS v1.0-Fatigue Short form 4a) | -2.42 T-score | Standard Deviation 9.46 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery | Physical Function (PROMIS v2.0 Physical Function Short Form 4a) | 0.84 T-score | Standard Deviation 6.05 |
Secondary
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)
Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, In the past 7 days, how would you rate your pain on average? Scored 0-10 from no pain to the worst imaginable pain.
Time frame: Baseline, 3 months
Population: Participants who completed the PROMIS measures at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Recruited | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.7 Score on scale | Standard Deviation 2.12 |
| Condition 2 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.36 Score on scale | Standard Deviation 1.33 |
| Condition 3 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.54 Score on scale | Standard Deviation 1.47 |
| Condition 4 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.51 Score on scale | Standard Deviation 1.94 |
| Condition 5 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.44 Score on scale | Standard Deviation 1.54 |
| Condition 6 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.62 Score on scale | Standard Deviation 1.99 |
| Condition 7 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.37 Score on scale | Standard Deviation 1.81 |
| Condition 8 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.68 Score on scale | Standard Deviation 1.72 |
| Condition 9 | Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) | 0.53 Score on scale | Standard Deviation 1.76 |
Secondary
Moderate-to-vigorous Physical Activity (Objective)
Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.
Time frame: Baseline, 3 months.
Population: ITT: all randomized participants using all available MVPA data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Recruited | Moderate-to-vigorous Physical Activity (Objective) | 52.78 min/wk |
| Condition 2 | Moderate-to-vigorous Physical Activity (Objective) | 70.12 min/wk |
| Condition 3 | Moderate-to-vigorous Physical Activity (Objective) | 69.70 min/wk |
| Condition 4 | Moderate-to-vigorous Physical Activity (Objective) | 53.20 min/wk |
| Condition 5 | Moderate-to-vigorous Physical Activity (Objective) | 75.94 min/wk |
| Condition 6 | Moderate-to-vigorous Physical Activity (Objective) | 46.96 min/wk |
| Condition 7 | Moderate-to-vigorous Physical Activity (Objective) | 69.23 min/wk |
| Condition 8 | Moderate-to-vigorous Physical Activity (Objective) | 53.67 min/wk |
p-value: 0.0295% CI: [9.95, 112.95]Mixed Models Analysis
Comparison: ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on MVPA change over time (from baseline to 3 months).p-value: 0.6595% CI: [-70.89, 113.61]Mixed Models Analysis
Comparison: ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on MVPA change over time (from baseline to 3 months).p-value: 0.295% CI: [-152.4, 32.39]Mixed Models Analysis
Comparison: ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on MVPA change over time (from baseline to 3 months).p-value: 0.5395% CI: [-63.07, 122.11]Mixed Models Analysis
Comparison: ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on MVPA change over time (from baseline to 3 months).p-value: 0.6695% CI: [-113.26, 72.27]Mixed Models Analysis
Secondary
Moderate-to-vigorous Physical Activity (Self-report)
Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the 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. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.
Time frame: Baseline, 3 months.
Population: ITT: all randomized participants using all PPAQ data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Recruited | Moderate-to-vigorous Physical Activity (Self-report) | 55.60 min/wk |
| Condition 2 | Moderate-to-vigorous Physical Activity (Self-report) | 34.13 min/wk |
| Condition 3 | Moderate-to-vigorous Physical Activity (Self-report) | 50.97 min/wk |
| Condition 4 | Moderate-to-vigorous Physical Activity (Self-report) | 38.76 min/wk |
| Condition 5 | Moderate-to-vigorous Physical Activity (Self-report) | 47.36 min/wk |
| Condition 6 | Moderate-to-vigorous Physical Activity (Self-report) | 42.37 min/wk |
| Condition 7 | Moderate-to-vigorous Physical Activity (Self-report) | 58.67 min/wk |
| Condition 8 | Moderate-to-vigorous Physical Activity (Self-report) | 31.06 min/wk |
p-value: 0.00495% CI: [14.39, 75.43]Mixed Models Analysis
Comparison: ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of simplified dietary monitoring (green vs. red) on self-reported MVPA change over time (from baseline to 3 months).p-value: 0.4795% CI: [-58.96, 28.32]Mixed Models Analysis
Comparison: ITT analysis for factor 2 (dietary goals) using linear mixed models comparing the effect of dietary goals (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).p-value: 0.4795% CI: [-27.67, 59.7]Mixed Models Analysis
Comparison: ITT analysis for factor 3 (supportive text messages) using linear mixed models comparing the effect of text messages (yes vs. no) on self-reported MVPA change over time (from baseline to 3 months).p-value: 0.6695% CI: [-34.09, 53.52]Mixed Models Analysis
Comparison: ITT analysis for factor 4 (lesson delivery) using linear mixed models comparing the effect of lesson timing (once vs. weekly) on self-reported MVPA change over time (from baseline to 3 months).p-value: 0.0695% CI: [-86.04, 1.73]Mixed Models Analysis
Secondary
Self-efficacy for Exercise and Nutrition
Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.
Time frame: Baseline, 3 months
Population: Participants who completed the Self-efficacy Scale for Exercise and Diet at 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Recruited | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | -0.3 Score on scale | Standard Deviation 3.8 |
| Participants Recruited | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.73 Score on scale | Standard Deviation 2.94 |
| Condition 2 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | 0.06 Score on scale | Standard Deviation 2.46 |
| Condition 2 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.39 Score on scale | Standard Deviation 2.53 |
| Condition 3 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | 0.58 Score on scale | Standard Deviation 3.71 |
| Condition 3 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.71 Score on scale | Standard Deviation 2.74 |
| Condition 4 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | -0.57 Score on scale | Standard Deviation 2.72 |
| Condition 4 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.46 Score on scale | Standard Deviation 2.73 |
| Condition 5 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | 0 Score on scale | Standard Deviation 3.34 |
| Condition 5 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 1.25 Score on scale | Standard Deviation 2.83 |
| Condition 6 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | -0.21 Score on scale | Standard Deviation 2.41 |
| Condition 6 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | -0.24 Score on scale | Standard Deviation 3.02 |
| Condition 7 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.53 Score on scale | Standard Deviation 2.43 |
| Condition 7 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | -0.27 Score on scale | Standard Deviation 2.72 |
| Condition 8 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | 0.03 Score on scale | Standard Deviation 3.59 |
| Condition 8 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.58 Score on scale | Standard Deviation 3.01 |
| Condition 9 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Exercise | -0.12 Score on scale | Standard Deviation 3.17 |
| Condition 9 | Self-efficacy for Exercise and Nutrition | Self-efficacy for Nutrition | 0.56 Score on scale | Standard Deviation 2.72 |
Secondary
Self-Regulation for Exercise and Nutrition
Changes in self-regulation from baseline to 3 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). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. 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. 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 exercise and diet at 3 months.
Time frame: Baseline, 3 months
Population: Participants who completed the Treatment Self-Regulation Questionnaire (TSRQ) for Exercise and Diet at 3 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Recruited | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.06 Score on scale | Standard Deviation 0.85 |
| Participants Recruited | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.07 Score on scale | Standard Deviation 0.88 |
| Participants Recruited | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | -0.01 Score on scale | Standard Deviation 0.61 |
| Participants Recruited | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0 Score on scale | Standard Deviation 0.96 |
| Condition 2 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.27 Score on scale | Standard Deviation 0.95 |
| Condition 2 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.09 Score on scale | Standard Deviation 0.761 |
| Condition 2 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | 0.02 Score on scale | Standard Deviation 0.71 |
| Condition 2 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.38 Score on scale | Standard Deviation 1.05 |
| Condition 3 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.11 Score on scale | Standard Deviation 0.89 |
| Condition 3 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | -0.13 Score on scale | Standard Deviation 0.89 |
| Condition 3 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.05 Score on scale | Standard Deviation 1.04 |
| Condition 3 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.17 Score on scale | Standard Deviation 0.87 |
| Condition 4 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.014 Score on scale | Standard Deviation 0.76 |
| Condition 4 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | 0.04 Score on scale | Standard Deviation 0.74 |
| Condition 4 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.28 Score on scale | Standard Deviation 0.76 |
| Condition 4 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.31 Score on scale | Standard Deviation 0.97 |
| Condition 5 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.14 Score on scale | Standard Deviation 0.95 |
| Condition 5 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.05 Score on scale | Standard Deviation 1.01 |
| Condition 5 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | 0.04 Score on scale | Standard Deviation 0.88 |
| Condition 5 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.03 Score on scale | Standard Deviation 1.12 |
| Condition 6 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.26 Score on scale | Standard Deviation 0.73 |
| Condition 6 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.20 Score on scale | Standard Deviation 0.7 |
| Condition 6 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.24 Score on scale | Standard Deviation 0.81 |
| Condition 6 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | 0.006 Score on scale | Standard Deviation 0.48 |
| Condition 7 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.44 Score on scale | Standard Deviation 0.82 |
| Condition 7 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.03 Score on scale | Standard Deviation 0.53 |
| Condition 7 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.12 Score on scale | Standard Deviation 0.8 |
| Condition 7 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.04 Score on scale | Standard Deviation 0.76 |
| Condition 8 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.02 Score on scale | Standard Deviation 1 |
| Condition 8 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.15 Score on scale | Standard Deviation 1.1 |
| Condition 8 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | -0.07 Score on scale | Standard Deviation 0.88 |
| Condition 8 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.11 Score on scale | Standard Deviation 0.85 |
| Condition 9 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Exercise | -0.07 Score on scale | Standard Deviation 0.8 |
| Condition 9 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Diet | 0.14 Score on scale | Standard Deviation 0.96 |
| Condition 9 | Self-Regulation for Exercise and Nutrition | Externally Controlled Motivation for Exercise | 0.19 Score on scale | Standard Deviation 0.88 |
| Condition 9 | Self-Regulation for Exercise and Nutrition | Autonomous Motivation for Diet | -0.02 Score on scale | Standard Deviation 0.8 |
Secondary
Weight (kg)
Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).
Time frame: Baseline, 3 months
Population: ITT: all randomized participants using all available weights.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Recruited | Weight (kg) | -1.47 pounds |
| Condition 2 | Weight (kg) | -2.39 pounds |
| Condition 3 | Weight (kg) | -1.26 pounds |
| Condition 4 | Weight (kg) | -2.60 pounds |
| Condition 5 | Weight (kg) | -2.32 pounds |
| Condition 6 | Weight (kg) | -1.54 pounds |
| Condition 7 | Weight (kg) | -2.23 pounds |
| Condition 8 | Weight (kg) | -1.63 pounds |