Stress Clinical Trial
Official title:
RELAX: A Mobile Application Suite Targeting Obesity and Stress
Verified date | March 2021 |
Source | University of Connecticut |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 ΒΌ 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Connecticut | Storrs | Connecticut |
Lead Sponsor | Collaborator |
---|---|
University of Connecticut | National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute |
United States,
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 |
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