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Completed

NCT Number: NCT03254953

GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-monitoring of body weight

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

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

weekly personalized feedback + lessons + action plans

Behavioral
  • these are additional evidence-based intervention components

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 1 month, 3 months

    Weight will be collected in kilograms using a calibrated digital scale

Secondary outcomes

  1. Proportion of Individuals Achieving ≥ 5% Weight Loss

    Time frame: Baseline to 3 months

    Weight will be collected in kilograms using a calibrated digital scale

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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).

  7. 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.

Other outcomes

  1. Physical Activity

    Time frame: Baseline, 3 months

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

  2. Sleep Quality

    Time frame: Baseline, 1 month, 3 months

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

  3. Perceived Stress

    Time frame: Baseline, 3 months

    Perceived Stress Scale (10 items)

  4. Depressive Symptoms

    Time frame: Baseline, 1 month, 3 months

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

  5. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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