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ObesityNCT03254953

GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

A study testing self-monitoring of body weight, self-monitoring of diet and weekly personalized feedback + lessons + action plans in people with Obesity and Overweight, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Obesity, Overweight, Weight Loss
What is being tested?
self-monitoring of body weight, self-monitoring of diet and weekly personalized feedback + lessons + action plans
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
19 Apr 2017to 2 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
self-monitoring of body weight, self-monitoring of diet, weekly personalized feedback + lessons + action plans
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
Medical subject headings
Obesity, Overweight, Weight Loss, Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-monitoring of body weightBehavioural

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

  • self-monitoring of dietBehavioural

    • 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 plansBehavioural

    • these are additional evidence-based intervention components
Study groups in NCT03254953
Study groupRoleWhat they receive
Sequential InterventionExperimental* 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
Receives: Behavioral: self-monitoring of body weight; Behavioral: self-monitoring of diet; Behavioral: weekly personalized feedback + lessons + action plans
Simultaneous InterventionExperimental* 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
Receives: 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)
Receives: Behavioral: self-monitoring of diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Weight will be collected in kilograms using a calibrated digital scale

    Measured: Baseline, 1 month, 3 months

Secondary outcomes (7)

  1. Proportion of Individuals Achieving ≥ 5% Weight Loss

    Weight will be collected in kilograms using a calibrated digital scale

    Measured: Baseline to 3 months

  2. 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

    Measured: Baseline, 3 months

  3. Change in Weight at 6 Months

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

    Measured: 6 months

  4. Self-Monitoring Engagement

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

    Measured: Baseline to 1-month and 3 months

  5. 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.

    Measured: Baseline, 1 month, 3 months

  6. Mastery

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

    Measured: Baseline, 1 month, 3 months

  7. 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.

    Measured: Baseline, 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start19 Apr 2017
  3. Primary completion11 Dec 2017
  4. Study completion2 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254953
Sponsor's protocol ID
D0822
Status last verified
Apr 2018
First submitted
7 Aug 2017
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.

Publications

  • 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.

    PubMed 30816851

Questions about this trial

What is this clinical trial studying?

A study testing self-monitoring of body weight, self-monitoring of diet and weekly personalized feedback + lessons + action plans in people with Obesity and Overweight, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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