RELAX: A Mobile Application Suite Targeting Obesity and Stress

Stress Clinical Trial

Official title:

RELAX: A Mobile Application Suite Targeting Obesity and Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615171
• Other study ID #: H17-217
• Secondary ID: 1R01HL122302-01A
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Stress
• Weight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Days App Used Over 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.	12 weeks
Primary	Usability	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.	12 weeks
Primary	Acceptability	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.	12 weeks
Primary	Burden	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.	12 weeks
Secondary	Percent Weight Change From Baseline to 12-Week Follow-Up	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).	12 weeks
Secondary	Change in Perceived Stress From Baseline to 12-Week Follow-Up	The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress.	12 weeks
Secondary	Change in Emotional Eating From Baseline to 12-Week Follow-Up	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.	12 weeks