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GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254953
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Obesity Overweight Weight Loss Behavioral: self-monitoring of body weight Behavioral: self-monitoring of diet Behavioral: weekly personalized feedback + lessons + action plans Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: GoalTracker: Comparing Self-Monitoring Strategies for Weight Loss: Does Developing Mastery Before Tracking Diet Enhance Engagement?
Actual Study Start Date : April 19, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline, 1 month, 3 months ]
    Weight will be collected in kilograms using a calibrated digital scale


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254953


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Michele G Lanpher, MA Duke University
Principal Investigator: Gary G Bennett, PhD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03254953    
Other Study ID Numbers: D0822
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This data set is initially being used for the principal investigator's (Michele Lanpher) doctoral dissertation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
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
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Body Weight Changes