GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

NCT03254953 | Completed

• 1 other identifier: D0822
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Weight Loss

Keywords

digital health; eHealth; technology; smartphone; obesity; overweight; weight loss; behavioral intervention; self-monitoring; tracking; engagement; adherence; weight change; e-mail; mobile application; goal setting; action plan; feedback; electronic health

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Weight will be collected in kilograms using a calibrated digital scale

  Baseline, 1 month, 3 months

Secondary Outcomes (7)

• Proportion of Individuals Achieving ≥ 5% Weight Loss

  Baseline to 3 months

• Change in Caloric Intake

  Baseline, 3 months

• Change in Weight at 6 Months

  6 months

• Self-Monitoring Engagement

  Baseline to 1-month and 3 months

• Self-Efficacy

  Baseline, 1 month, 3 months

Other Outcomes (5)

• Physical Activity

  Baseline, 3 months

• Sleep Quality

  Baseline, 1 month, 3 months

• Perceived Stress

  Baseline, 3 months

Study Arms (3)

Sequential Intervention

EXPERIMENTAL

* 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; Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans

Simultaneous Intervention

EXPERIMENTAL

* 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; Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans

Control (diet-tracking only)

EXPERIMENTAL

* 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

Interventions

self-monitoring of body weight BEHAVIORAL

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

Sequential Intervention; Simultaneous Intervention

self-monitoring of diet 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

Control (diet-tracking only); Sequential Intervention; Simultaneous Intervention

weekly personalized feedback + lessons + action plans BEHAVIORAL

\- these are additional evidence-based intervention components

Sequential Intervention; Simultaneous Intervention

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 30816851 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Body Weight Changes

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele G Lanpher, MA

  Duke University

  PRINCIPAL INVESTIGATOR

• Gary G Bennett, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 obese

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 21, 2017
• Study Start: April 19, 2017
• Primary Completion: December 11, 2017
• Study Completion: March 2, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)