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Clinical Trials/NCT02615171
NCT02615171
Completed
Not Applicable

RELAX: A Mobile Application Suite Targeting Obesity and Stress

University of Connecticut1 site in 1 country64 target enrollmentJuly 8, 2019
ConditionsStressWeight

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Connecticut
Enrollment
64
Locations
1
Primary Endpoint
Usability
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2019
End Date
November 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherry Pagoto

Professor

University of Connecticut

Eligibility 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;

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Percent Weight Change From Baseline to 12-Week Follow-Up(12 weeks)
  • Change in Emotional Eating From Baseline to 12-Week Follow-Up(12 weeks)
  • Change in Perceived Stress From Baseline to 12-Week Follow-Up(12 weeks)

Study Sites (1)

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