GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Duke University

Status: Completed

Conditions: Weight Loss; Overweight; Obesity

Treatments: Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans; Behavioral: self-monitoring of body weight

Study type: Interventional

Funder types: Other

Identifiers

NCT03254953

D0822

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Sequential Intervention

Experimental group

Description:

* 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

Treatment:

Behavioral: self-monitoring of diet

Behavioral: self-monitoring of body weight

Behavioral: weekly personalized feedback + lessons + action plans

Simultaneous Intervention

Experimental group

Description:

* 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

Treatment:

Behavioral: self-monitoring of diet

Behavioral: self-monitoring of body weight

Behavioral: weekly personalized feedback + lessons + action plans

Control (diet-tracking only)

Experimental group

Description:

* 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)

Treatment:

Behavioral: self-monitoring of diet