GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Study Overview
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Brief Summary
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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
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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... 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. Determine the effect of the Sequential self-monitoring intervention, compared to the Control, on the same variables. Compare self-monitoring engagement by intervention arm. Examine the relation between self-monitoring engagement and weight loss. Investigate theoretical mediators (self-efficacy, mastery, and self-regulation) on the relation between treatment arm and weight change.

Official Title
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GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss: Does Developing Mastery Before Tracking Diet Enhance Engagement?

Conditions
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Obesity, Overweight, Weight Loss

Intervention / Treatment
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* Behavioral: self-monitoring of body weight
* Behavioral: self-monitoring of diet
* Behavioral: weekly personalized feedback + lessons + action plans


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Intervention<br>in this Sequential eHealth intervention, participants are asked to self-monitor only their body weight for the first month, then for months 2 and 3 they will be asked to also self-monitor their diet participants are asked to use the MyFitnessPal app for self-monitoring given goal to lose 5% weight by end of intervention (3 months) weekly personalized feedback via email weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email weekly action plans via email | Behavioral: self-monitoring of body weight<br>* - weigh daily for 3 months and track their weight using the MyFitnessPal mobile app<br>Behavioral: self-monitoring of diet<br>* 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<br>Behavioral: weekly personalized feedback + lessons + action plans<br>* - these are additional evidence-based intervention components<br>|
| Experimental: Simultaneous Intervention<br>in this Simultaneous eHealth intervention, participants are asked to self-monitor both their body weight and diet for 3 months participants are asked to use the MyFitnessPal app for self-monitoring given goal to lose 5% weight by end of intervention (3 months) weekly personalized feedback via email weekly skills training materials (behavioral modification lessons; tips on using different features of the app) via email weekly action plans via email | Behavioral: self-monitoring of body weight<br>* - weigh daily for 3 months and track their weight using the MyFitnessPal mobile app<br>Behavioral: self-monitoring of diet<br>* 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<br>Behavioral: weekly personalized feedback + lessons + action plans<br>* - these are additional evidence-based intervention components<br>|
| Experimental: Control (diet-tracking only)<br>participants are asked to self-monitor their diet for 3 months participants are asked to use the MyFitnessPal app for self-monitoring given goal to lose 5% weight by end of intervention (3 months) | Behavioral: self-monitoring of diet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Weight will be collected in kilograms using a calibrated digital scale | Baseline, 1 month, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Individuals Achieving ≥ 5% Weight Loss | Weight will be collected in kilograms using a calibrated digital scale | Baseline to 3 months | 
| Change in Caloric Intake | 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 | Baseline, 3 months | 
| Change in Weight at 6 Months | At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected | 6 months | 
| Self-Monitoring Engagement | Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet | Baseline to 1-month and 3 months | 
| Self-Efficacy | 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. | Baseline, 1 month, 3 months | 
| Mastery | The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each). | Baseline, 1 month, 3 months | 
| Self-Regulation | 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. | Baseline, 1 month, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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