Clinical trial NCT02615171: RELAX: A Mobile Application Suite Targeting Obesity and Stress
Official title: RELAX: A Mobile Application Suite Targeting Obesity and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Weight
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-11-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
* 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

Primary outcomes:
measure: Percentage of Days App Used Over 12 Weeks
timeFrame: 12 weeks
measure: Usability
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Burden
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Weight Change From Baseline to 12-Week Follow-Up
timeFrame: 12 weeks
measure: Change in Perceived Stress From Baseline to 12-Week Follow-Up
timeFrame: 12 weeks
measure: Change in Emotional Eating From Baseline to 12-Week Follow-Up
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References:
citation: 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.