Obesity, Overweight, Weight Loss
Conditions
Keywords
digital health, eHealth, technology, smartphone, obesity, overweight, weight loss, behavioral intervention, self-monitoring, tracking, engagement, adherence, weight change, e-mail, mobile application, goal setting, action plan, feedback, electronic health
Brief summary
This study is a randomized controlled trial that compares 3 self-monitoring approaches for weight loss. GoalTracker is a standalone, technology-based intervention using a commercial smartphone app (MyFitnessPal) and email. The investigators hypothesize that the group that delays diet tracking and receives additional intervention components (weekly personalized feedback, skills training, and action plans) will have greater weight loss at the end of the 12-week intervention and at 6-month followup, compared to (a) an intervention group that simultaneously tracks weight and diet for all 12 weeks and receives the same additional components, and (b) a control group that tracks only diet.
Detailed description
This study will examine whether a digital health intervention (GoalTracker) can promote weight loss among adults who are overweight or obese. Engagement in self-monitoring often declines over time, which is then associated with suboptimal weight loss. Finding ways to improve self-monitoring engagement, particularly in the first month of treatment, is needed. Promoting mastery, self-efficacy, and self-regulatory skills may help with maintaining high engagement. The investigators aim to enroll 105 participants. All groups are asked to self-monitor daily on their smartphone using the free commercial mobile application MyFitnessPal over the course of the 12-week intervention. Specifically, the study aims to... 1. Determine the effect of a Sequential self-monitoring intervention, compared to a Simultaneous self-monitoring intervention on weight change, caloric intake change, and proportion of individuals achieving 5% weight loss. 2. Determine the effect of the Sequential self-monitoring intervention, compared to the Control, on the same variables. 3. Compare self-monitoring engagement by intervention arm. 4. Examine the relation between self-monitoring engagement and weight loss. 5. Investigate theoretical mediators (self-efficacy, mastery, and self-regulation) on the relation between treatment arm and weight change.
Interventions
BEHAVIORALself-monitoring of body weight
\- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app
BEHAVIORALself-monitoring of diet
* track their diet (food and drinks) daily using the MyFitnessPal mobile app * when they are asked to track diet will vary based on the arm
BEHAVIORALweekly personalized feedback + lessons + action plans
\- these are additional evidence-based intervention components
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
12-week randomized controlled trial to compare 3 self-monitoring approaches for weight loss in a digital health intervention for adults who are overweight or obese
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ages 21-65 years old * Body Mass Index (BMI) 25-45 kg/m2 * interested in losing weight through dietary change * current use of iPhone or Android smartphone * current use of email address * has daily access to a bathroom scale * no recent weight loss (≥10 lbs) in the past 6 months * able to read and write in English * able to attend 3 in-person evaluation visits at Duke University in Durham, North Carolina over a 3-month period
Exclusion criteria
* current participation in another weight loss treatment * currently pregnant or planning to become pregnant within study period, or \< 1 year post-partum * history of cardiovascular event, eating disorder, diabetes mellitus, hypothyroidism, cancer, end stage renal disease * current uncontrolled hypertension * use of the MyFitnessPal app to track food in the past 6 months * Former or planned bariatric surgery * current use of medication (e.g., lithium, steroids, anti-psychotics) * use of weight loss medication in past 6 months * profound cognitive, developmental, or psychiatric disorders or recent hospitalization in a psychiatric facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, 1 month, 3 months | Weight will be collected in kilograms using a calibrated digital scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caloric Intake | Baseline, 3 months | Caloric intake will will be assessed using the Automated Self-Administered 24-hour Dietary Intake Assessment (ASA24), an online dietary recall tool developed by the National Cancer Institute |
| Change in Weight at 6 Months | 6 months | At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected |
| Self-Monitoring Engagement | Baseline to 1-month and 3 months | Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet |
| Self-Efficacy | Baseline, 1 month, 3 months | Weight Efficacy Lifestyle Questionnaire (WEL) (20 items) will assess self-efficacy for eating. Separate surveys that were adapted will assess self-efficacy for self-monitoring of diet and weight. |
| Mastery | Baseline, 1 month, 3 months | The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each). |
| Self-Regulation | Baseline, 1 month, 3 months | The Three Factor Eating Questionnaire-R18 (TFEQ-R18) (18 items) will assess self-regulation for controlled eating. Separate surveys that were adapted will assess self-regulation for self-monitoring of diet and weight. |
| Proportion of Individuals Achieving ≥ 5% Weight Loss | Baseline to 3 months | Weight will be collected in kilograms using a calibrated digital scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | Baseline, 3 months | Perceived Stress Scale (10 items) |
| Depressive Symptoms | Baseline, 1 month, 3 months | Patient Health Questionnaire (PHQ-8) will assess depressive symptoms. |
| Health-Related Quality of Life | Baseline, 1 month, 3 months | EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life. |
| Sleep Quality | Baseline, 1 month, 3 months | Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality. |
| Physical Activity | Baseline, 3 months | Paffenbarger Activity Questionnaire (7 items) will assess physical activity. |
Countries
United States
Outcome results
None listed