Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness
Completed · Not applicable
Conditions studied: Serious Mental Illness
In brief
This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR\&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools. Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight
Key facts
- Study ID
- NCT04560335
- Run by
- VA Office of Research and Development
- People needed
- 257
- Starts
- 2021-08-02
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis;
- age 18 and over;
- BMI >= 30.0 (obese); and
- ownership of a phone running Android OS or iOS (iPhone).
You may not qualify if…
- chart diagnosis of dementia;
- history of bariatric surgery;
- pregnant and nursing mothers;
- patient has a conservator/legally authorized representative who makes their medical decisions;
- psychiatric hospitalization during the month prior to enrollment.
- Additionally, we will follow the American College of Sports Medicine recommendations for health screening and risk stratification in preparation for starting a moderate intensity exercise program to ensure that participants enrolled are capable of safely engaging in the app's recommendations regarding physical activity. Specifically, all potential participants will be given the Physical Activity Readiness Questionnaire (PAR-Q), a screening tool often used in weight management trials. If they endorse symptoms or major signs suggestive of cardiopulmonary disease (i.e., angina, anginal equivalent, dyspnea, syncope, orthopnea, edema, palpitations or claudication), which is a score >=1 on the PAR-Q, they will need clearance from a VA physician before enrolling.
Where it is running
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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