GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Not Applicable

Completed

• Conditions: Overweight; Obesity; Weight Loss
• Interventions: Behavioral: self-monitoring of body weight; Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans

• Registration Number: NCT03254953
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2017-04-19
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Primary Completion: 2017-12-11
• Study Completion: 2018-03-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential Intervention	weekly personalized feedback + lessons + action plans	* 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
Simultaneous Intervention	self-monitoring of body weight	* 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
Sequential Intervention	self-monitoring of body weight	* 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
Sequential Intervention	self-monitoring of diet	* 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
Control (diet-tracking only)	self-monitoring of diet	* 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)
Simultaneous Intervention	self-monitoring of diet	* 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
Simultaneous Intervention	weekly personalized feedback + lessons + action plans	* 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

Primary Outcome Measures

Name	Time	Method
Change in Weight	Baseline, 1 month, 3 months	Weight will be collected in kilograms using a calibrated digital scale

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States