GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

April 24, 2018 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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...

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Weight
Time Frame: Baseline, 1 month, 3 months
Weight will be collected in kilograms using a calibrated digital scale
Baseline, 1 month, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Individuals Achieving ≥ 5% Weight Loss
Time Frame: Baseline to 3 months
Weight will be collected in kilograms using a calibrated digital scale
Baseline to 3 months
Change in Caloric Intake
Time Frame: 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
Baseline, 3 months
Change in Weight at 6 Months
Time Frame: 6 months
At 6-months (i.e., 3 months post-intervention), self-reported weight will be collected
6 months
Self-Monitoring Engagement
Time Frame: Baseline to 1-month and 3 months
Frequency of self-monitoring weight and diet; Consistency of self-monitoring weight and diet
Baseline to 1-month and 3 months
Self-Efficacy
Time Frame: 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.
Baseline, 1 month, 3 months
Mastery
Time Frame: 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).
Baseline, 1 month, 3 months
Self-Regulation
Time Frame: 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.
Baseline, 1 month, 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: Baseline, 3 months
Paffenbarger Activity Questionnaire (7 items) will assess physical activity.
Baseline, 3 months
Sleep Quality
Time Frame: Baseline, 1 month, 3 months
Medical Outcomes Study (MOS) Sleep (12 items) will assess sleep quality.
Baseline, 1 month, 3 months
Perceived Stress
Time Frame: Baseline, 3 months
Perceived Stress Scale (10 items)
Baseline, 3 months
Depressive Symptoms
Time Frame: Baseline, 1 month, 3 months
Patient Health Questionnaire (PHQ-8) will assess depressive symptoms.
Baseline, 1 month, 3 months
Health-Related Quality of Life
Time Frame: Baseline, 1 month, 3 months
EuroQol-5 Dimension (EQ-5D) (5 items) will assess health-related quality of life.
Baseline, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michele G Lanpher, MA, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D0822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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