RELAX: A Mobile Application Suite Targeting Obesity and Stress

NCT02615171 | Completed Results DMC

• 2 other identifiers: H17-2171R01HL122302-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Weight

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Percent Weight Change From Baseline to 12-Week Follow-Up

  12 weeks

• Change in Perceived Stress From Baseline to 12-Week Follow-Up

  12 weeks

• Change in Emotional Eating From Baseline to 12-Week Follow-Up

  12 weeks

Study Arms (2)

Comprehensive Dietary Self-Monitoring

ACTIVE COMPARATOR

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

Simple Dietary Self-Monitoring

ACTIVE COMPARATOR

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

Interventions

Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity BEHAVIORAL

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.

Comprehensive Dietary Self-Monitoring

Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity BEHAVIORAL

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.

Simple Dietary Self-Monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a BMI of 27-45
• Currently use an Android smartphone
• Have cell phone connectivity at home and work
• Uses a smartphone every day

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Connecticut: lead
• Worcester Polytechnic Institute: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

• Pagoto S, Tulu B, Waring ME, Goetz J, Bibeau J, Divito J, Groshon L, Schroeder M. Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24249. doi: 10.2196/24249.

  PMID: 33792547 DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sherry Pagoto
• Organization: University of Connecticut

Sherry.Pagoto@uconn.edu

8604868979

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 26, 2015
• Study Start: July 8, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 13, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-03

Locations

US (1)