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GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Primary Purpose

Obesity, Overweight, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

self-monitoring of body weight

self-monitoring of diet

weekly personalized feedback + lessons + action plans

About this trial

This is an interventional treatment trial for Obesity focused on measuring 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

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Sequential Intervention

Simultaneous Intervention

Control (diet-tracking only)

Arm 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

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

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)

Outcomes

Primary Outcome Measures

Change in Weight

Weight will be collected in kilograms using a calibrated digital scale

Secondary Outcome Measures

Proportion of Individuals Achieving ≥ 5% Weight Loss

Weight will be collected in kilograms using a calibrated digital scale

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

Change in Weight at 6 Months

At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected

Self-Monitoring Engagement

Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet

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.

Mastery

The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each).

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.

Full Information

NCT ID

NCT03254953

First Posted

August 7, 2017

Last Updated

April 24, 2018

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03254953

Brief Title

GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 19, 2017 (Actual)

Primary Completion Date

December 11, 2017 (Actual)

Study Completion Date

March 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 obese

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequential Intervention

Arm Type

Experimental

Arm Description

Arm Title

Simultaneous Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control (diet-tracking only)

Arm Type

Experimental

Arm 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)

Intervention Type

Behavioral

Intervention Name(s)

self-monitoring of body weight

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

self-monitoring of diet

Intervention Description

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

Intervention Name(s)

weekly personalized feedback + lessons + action plans

Intervention Description

- these are additional evidence-based intervention components

Primary Outcome Measure Information:

Title

Change in Weight

Description

Weight will be collected in kilograms using a calibrated digital scale

Time Frame

Baseline, 1 month, 3 months

Secondary Outcome Measure Information:

Title

Proportion of Individuals Achieving ≥ 5% Weight Loss

Description

Weight will be collected in kilograms using a calibrated digital scale

Time Frame

Baseline to 3 months

Title

Change in Caloric Intake

Description

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

Time Frame

Baseline, 3 months

Title

Change in Weight at 6 Months

Description

At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected

Time Frame

6 months

Title

Self-Monitoring Engagement

Description

Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet

Time Frame

Baseline to 1-month and 3 months

Title

Self-Efficacy

Description

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.

Time Frame

Baseline, 1 month, 3 months

Title

Mastery

Description

The Automaticity subscale of The Self-Report Habit Index (SRHI) will assess mastery of self-monitoring diet and weight (4 items each).

Time Frame

Baseline, 1 month, 3 months

Title

Self-Regulation

Description

Time Frame

Baseline, 1 month, 3 months

Other Pre-specified Outcome Measures:

Title

Physical Activity

Description

Paffenbarger Activity Questionnaire (7 items) will assess physical activity.

Time Frame

Baseline, 3 months

Title

Sleep Quality

Description

Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.

Time Frame

Baseline, 1 month, 3 months

Title

Perceived Stress

Description

Perceived Stress Scale (10 items)

Time Frame

Baseline, 3 months

Title

Depressive Symptoms

Description

Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.

Time Frame

Baseline, 1 month, 3 months

Title

Health-Related Quality of Life

Description

EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.

Time Frame

Baseline, 1 month, 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michele G Lanpher, MA

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gary G Bennett, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.

Citations:

PubMed Identifier

30816851

Citation

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.

Results Reference

derived

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GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

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