GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254953
• Other study ID #: D0822
• Status: Completed
• Phase: N/A
• First received: August 7, 2017
• Last updated: April 24, 2018
• Start date: April 19, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: April 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2, 2018
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• self-monitoring of body weight
- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app
• 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
• weekly personalized feedback + lessons + action plans
- these are additional evidence-based intervention components

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity	Paffenbarger Activity Questionnaire (7 items) will assess physical activity.	Baseline, 3 months
Other	Sleep Quality	Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.	Baseline, 1 month, 3 months
Other	Perceived Stress	Perceived Stress Scale (10 items)	Baseline, 3 months
Other	Depressive Symptoms	Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.	Baseline, 1 month, 3 months
Other	Health-Related Quality of Life	EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.	Baseline, 1 month, 3 months
Primary	Change in Weight	Weight will be collected in kilograms using a calibrated digital scale	Baseline, 1 month, 3 months
Secondary	Proportion of Individuals Achieving = 5% Weight Loss	Weight will be collected in kilograms using a calibrated digital scale	Baseline to 3 months
Secondary	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
Secondary	Change in Weight at 6 Months	At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected	6 months
Secondary	Self-Monitoring Engagement	Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet	Baseline to 1-month and 3 months
Secondary	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
Secondary	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
Secondary	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