RELAX: A Mobile Application Suite Targeting Obesity and Stress

• ClinicalTrials.gov Identifier: NCT02615171
• Recruitment Status: Active, not recruiting
• First Posted: November 26, 2015
• Last Update Posted: November 4, 2019
• Sponsor: University of Connecticut
• Collaborators: Worcester Polytechnic Institute; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Sherry Pagoto, University of Connecticut

Study Description

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.

Study Design

• 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
• Estimated Primary Completion Date: November 30, 2019
• Estimated Study Completion Date: November 30, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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)

More 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
• Last Update Posted: November 4, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms