Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RELAX: A Mobile Application Suite Targeting Obesity and Stress

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: 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

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.

Condition or disease Intervention/treatment Phase
Stress Weight Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RELAX: A Mobile Application Suite Targeting Obesity and Stress
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02615171


Locations
Layout table for location information
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
  Study Documents (Full-Text)

Documents provided by Sherry Pagoto, University of Connecticut:
Study Protocol  [PDF] March 15, 2019
Statistical Analysis Plan  [PDF] October 29, 2020
Informed Consent Form  [PDF] August 31, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sherry Pagoto, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT02615171    
Other Study ID Numbers: H17-217
1R01HL122302-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2015    Key Record Dates
Results First Posted: March 11, 2021
Last Update Posted: April 13, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight