GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss
• Intervention / Treatment: Behavioral: self-monitoring of body weight; Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequential Intervention; 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; - weigh daily for 3 months and track their weight using the MyFitnessPal mobile app; Behavioral: self-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; Behavioral: weekly personalized feedback + lessons + action plans; - these are additional evidence-based intervention components
Experimental: Simultaneous Intervention; 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; - weigh daily for 3 months and track their weight using the MyFitnessPal mobile app; Behavioral: self-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; Behavioral: weekly personalized feedback + lessons + action plans; - these are additional evidence-based intervention components
Experimental: Control (diet-tracking only); 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Paffenbarger Activity Questionnaire (7 items) will assess physical activity.	Baseline, 3 months
Sleep Quality	Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.	Baseline, 1 month, 3 months
Perceived Stress	Perceived Stress Scale (10 items)	Baseline, 3 months
Depressive Symptoms	Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.	Baseline, 1 month, 3 months
Health-Related Quality of Life	EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.	Baseline, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Michele G Lanpher, MA, Duke University

Publications and helpful links

General Publications

• Patel ML, Hopkins CM, Brooks TL, Bennett GG. Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 28;7(2):e12209. doi: 10.2196/12209.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): March 2, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: behavioral intervention; obesity; overweight; adherence; smartphone; feedback; weight loss; eHealth; digital health; self-monitoring; technology; mobile application; weight change; engagement; action plan; goal setting; electronic health; tracking; e-mail
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: D0822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No