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RELAX: A Mobile Application Suite Targeting Obesity and Stress

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ClinicalTrials.gov Identifier: NCT02615171
Recruitment Status : Not yet recruiting
First Posted : November 26, 2015
Last Update Posted : May 29, 2019
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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated 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. App usage [ Time Frame: 12 weeks ]
    Self-reported app usage

  2. Usability [ Time Frame: 12 weeks ]
    Usability will be assessed using the System Usability Scale. 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.

  3. Acceptability [ Time Frame: 12 weeks ]
    Acceptability of the app will be assessed on visual analogue scales.

  4. Burden [ Time Frame: 12 weeks ]
    Participants will rate how burdensome (on 0-10 scales) the app was to use.


Secondary Outcome Measures :
  1. Percent Weight Change from Baseline [ Time Frame: 12 weeks ]
    A digital scale (Scaletronix, Model-5002) will be used to record weight.

  2. Perceived Stress [ Time Frame: 12 weeks ]
    The Perceived Stress Scale is a 14-item measure of perceived stress.

  3. Emotional eating [ Time Frame: 12 weeks ]
    EDEQ is a 38-item scale assessing core features of eating disorders, including emotional eating



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Phone connectivity at home and work
  • Have written clearance from their PCP
  • Willing to use the Nexus (Google) smartphone that runs on the Android operating system.

Exclusion Criteria:

  1. Under the age of 18 or over the age of 65;
  2. BMI under 30 or over 45;
  3. Does not currently own a smartphone;
  4. Not phone connectivity at home and work;
  5. Unable to collect medical clearance;
  6. Unable to walk unaided for 1/4 mile without stopping;
  7. Taking medications known to affect appetite and/or weight;
  8. Has a condition which precludes dietary changes (i.e. ulcerative colitis, Crohn's disease, active diverticulitis, renal disease);
  9. Type 1 or 2 diabetes;
  10. Had gastric bypass surgery;
  11. Plans to have gastric bypass surgery during the study period;
  12. Pregnant/lactating;
  13. Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression;
  14. Had bariatric surgery or recently lost significant weight;
  15. On medication affecting weight;
  16. Unwillingness of the patient's PCP to participate (phase 4 RELAX-AS condition only)
  17. Prisoner; or
  18. Unable to provide consent

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


Contacts
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Contact: Jessica Oleski 860-486-8979 mhealthstudy@uconn.edu
Contact: Jared Goetz 860-486-8772 mhealthstudy@uconn.edu

Locations
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United States, Connecticut
University of Connecticut Not yet recruiting
Storrs, Connecticut, United States, 06269
Contact: Sherry Pagoto, PhD    860-486-2313    sherry.pagoto@uconn.edu   
Sponsors and Collaborators
University of Connecticut
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Sherry Pagoto, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT02615171     History of Changes
Other Study ID Numbers: H17-217
1R01HL122302-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms