GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

NCT ID: NCT03254953

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2018-03-02

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.

Conditions

Obesity; Overweight; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

self-monitoring of body weight

Intervention Type: BEHAVIORAL

\- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app

self-monitoring of diet

Intervention Type: BEHAVIORAL

• 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

weekly personalized feedback + lessons + action plans

Intervention Type: BEHAVIORAL

\- these are additional evidence-based intervention components

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

Group Type: EXPERIMENTAL

self-monitoring of body weight

Intervention Type: BEHAVIORAL

\- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app

self-monitoring of diet

Intervention Type: BEHAVIORAL

• 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

weekly personalized feedback + lessons + action plans

Intervention Type: BEHAVIORAL

\- these are additional evidence-based intervention components

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)

Group Type: EXPERIMENTAL

self-monitoring of diet

Intervention Type: BEHAVIORAL

• 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

Interventions

self-monitoring of body weight

\- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app

Intervention Type: 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

Intervention Type: BEHAVIORAL

weekly personalized feedback + lessons + action plans

\- these are additional evidence-based intervention components

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele G Lanpher, MA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Gary G Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30816851 (View on PubMed)

Other Identifiers

D0822

Identifier Type: -

Identifier Source: org_study_id