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Trial record 1 of 1 for:    1R01HL122302-01A1
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RELAX: A Mobile Application Suite Targeting Obesity and Stress

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ClinicalTrials.gov Identifier: NCT02615171
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : March 11, 2021
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherry Pagoto, University of Connecticut

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE November 26, 2015
Results First Submitted Date  ICMJE October 30, 2020
Results First Posted Date  ICMJE March 11, 2021
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE July 8, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
  • Percentage of Days App Used Over 12 Weeks [ Time Frame: 12 weeks ]
    App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period.
  • Usability [ Time Frame: 12 weeks ]
    Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends.
  • Acceptability [ Time Frame: 12 weeks ]
    Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: "Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful" (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree.
  • Burden [ Time Frame: 12 weeks ]
    At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • RELAX App usage [ Time Frame: 6 month follow-up ]
    Phones will keep a downloadable record usage of all features individually
  • Self-monitoring adherence to the intervention components [ Time Frame: 6-month follow-up ]
    Self-monitoring frequency data will be extracted remotely from phone entries
  • Visit attendance during the intervention [ Time Frame: 6-month follow-up ]
    Attendance will be tracked as completed or missed
  • System Usability Scale [ Time Frame: 6-month follow-up ]
    Usability will be assessed using the SUS. It is a 10-item 5-point Likert scale a score above 58 is regarded as above average, and a SUS score above 80 is regarded as high and a score where participants are likely to recommend the product to friends.
  • Intervention Fidelity of the interventionists [ Time Frame: 6-month follow-up ]
    Intervention sessions will be audiotaped. Blinded evaluators will listen to and rate 25% of visits.
  • Acceptability of the RELAX app [ Time Frame: 6-month follow-up ]
    Acceptability and their satisfaction with intervention components will be measured. Participants will answer questions about every aspect of each intervention component.
  • Burden of intervention [ Time Frame: 6-month follow-up ]
    We will ask participants how burdensome (on 0-10 scales) each app feature was. We will compare average burden scores across all app features.
  • Clinician time spent during intervention [ Time Frame: 6-month follow-up ]
    Clinicians report the amount of time they spent each week reviewing the web-based interface and in session
  • Cost associated with interventions [ Time Frame: 6-month follow-up ]
    We will systematically track all costs associated with delivery of all 3 intervention conditions. We will create an accounting system that captures administrative, intervention and participant costs. We will approximate total costs by combining intervention costs and participant time costs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2021)
  • Percent Weight Change From Baseline to 12-Week Follow-Up [ Time Frame: 12 weeks ]
    A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF).
  • Change in Perceived Stress From Baseline to 12-Week Follow-Up [ Time Frame: 12 weeks ]
    The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress.
  • Change in Emotional Eating From Baseline to 12-Week Follow-Up [ Time Frame: 12 weeks ]
    Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Weight [ Time Frame: Baseline ]
    A digital scale (Scaletronix, Model-5002) will be used to record weight.
  • Weight [ Time Frame: 6-month follow-up ]
    A digital scale (Scaletronix, Model-5002) will be used to record weight.
  • Perceived Stress Scale [ Time Frame: Baseline ]
    The Perceived Stress Scale is a 14-item measure of perceived stress.
  • Perceived Stress Scale [ Time Frame: 6-month follow-up ]
    The Perceived Stress Scale is a 14-item measure of perceived stress.
  • Eating Disorder Examination Questionnaire [ Time Frame: Baseline ]
    EDEQ is a 38-item scale assessing core features of eating disorders, including emotional eating
  • Eating Disorder Examination Questionnaire [ Time Frame: 6-month follow-up ]
    EDEQ is a 38-item scale assessing core features of eating disorders, including emotional eating
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RELAX: A Mobile Application Suite Targeting Obesity and Stress
Official Title  ICMJE RELAX: A Mobile Application Suite Targeting Obesity and Stress
Brief Summary This research is being done is to evaluate the feasibility and acceptability of a novel weight loss mobile app that was designed to be less burdensome than traditional weight loss apps.
Detailed Description

Obesity and stress are highly comorbid and both increase risk for cardiovascular disease (CVD). Stress is associated with disinhibited eating, junk food consumption and low consumption of produce and whole grains. Both stress and stress-induced eating are not only associated with obesity but also predict worst outcomes in lifestyle interventions. Stress and stress-induced eating should be targeted in interventions to maximize weight loss; however, this makes for a very intensive intervention. Technology could be leveraged to reduce intervention burden.

In this trial investigators propose to compare the feasibility, usability, acceptability, and burden of an traditional weight loss app that includes diet and physical activity self-monitoring features to an app (Slip Buddy) we developed that focuses on self-monitoring of stress eating. With Slip Buddy, the user is just asked to track overeating episodes, indicating when they are triggered by stress. The majority of weight loss apps are burdensome to users by requiring them to self-monitor diet and exercise. They also ignore major barriers to weight loss, such as stress. This work moves the field forward by addressing user burden and an important barrier to weight loss.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress
  • Weight
Intervention  ICMJE
  • Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity
    The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
  • Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
    Arm: Active Comparator: Simple Dietary Self-Monitoring he intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Study Arms  ICMJE
  • Active Comparator: Comprehensive Dietary Self-Monitoring
    The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
    Intervention: Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity
  • Active Comparator: Simple Dietary Self-Monitoring
    The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
    Intervention: Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Publications * Pagoto S, Tulu B, Waring ME, Goetz J, Bibeau J, Divito J, Groshon L, Schroeder M. Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24249. doi: 10.2196/24249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
60
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a BMI of 27-45
  • Currently use an Android smartphone
  • Have cell phone connectivity at home and work
  • Uses a smartphone every day

Exclusion Criteria:

  • Under the age of 18 and over the age of 65;
  • BMI under 27 or over 45;
  • Not interested in losing weight;
  • Does not currently own a smartphone;
  • Smartphone type and/or version not meeting app requirements;
  • No phone connectivity at home and work;
  • Unable to walk unaided for ¼ mile without stopping;
  • Has a condition that precludes dietary changes (i.e. ulcerative colitis, Crohn's disease, active diverticulitis, renal disease);
  • On a medication affecting weight;
  • Type 1 or 2 diabetes;
  • Had gastric bypass surgery;
  • Had or plans to have gastric bypass surgery during the study period;
  • Pregnant/lactating;
  • Has bipolar disorder, substance abuse, bulimia, or severe depression;
  • Lost 5% or more body weight in the last 3 months;
  • Has not experienced emotional eating over the last week;
  • On medication affecting weight;
  • Has concerns about being audiotaped;
  • Prisoner;
  • Unable to provide consent; or
  • Non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615171
Other Study ID Numbers  ICMJE H17-217
1R01HL122302-01A1 ( U.S. NIH Grant/Contract )" onClick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=1R01HL122302-01A1&Fy=all'); return false">1R01HL122302-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sherry Pagoto, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE
  • Worcester Polytechnic Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account University of Connecticut
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP