GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT03254953

Collaborator

(none)

105

Enrollment

Location

Arms

10.4

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Weight Loss	Behavioral: self-monitoring of body weight Behavioral: self-monitoring of diet Behavioral: weekly personalized feedback + lessons + action plans	N/A

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...

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 obese12-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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 19, 2017

Actual Primary Completion Date :

Dec 11, 2017

Actual Study Completion Date :

Mar 2, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Weight [Baseline, 1 month, 3 months]
Weight will be collected in kilograms using a calibrated digital scale

Secondary Outcome Measures

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
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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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