Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness

Not Applicable

Active, not recruiting

• Conditions: Serious Mental Illness

• Registration Number: NCT04560335
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

Detailed Description

Between 40% to 60% of individuals with serious mental illness (SMI) are obese. Obesity and physical inactivity result in increased rates of chronic diseases, increased risk of death, and substantial health care costs. Treatment guidelines recommend that individuals with SMI who are overweight should be offered evidence-based weight loss interventions, including psychosocial interventions. The VA's weight management program, MOVE!, is attended by less than 5% of the overweight population and is not adapted to the cognitive needs and patient preferences for the population with SMI. Effective adapted weight management programs are not offered in VA because the programs are time-intensive and require the skills of trained providers who are often in short-supply. CoachToFit can address this gap in care. CoachToFit is a weight management program, adapted for the population with SMI, that includes a smartphone app delivering evidence-based weight management services with weekly telephonic support from a VA peer specialist who acts as a wellness coach. Peer specialists are individuals who draw upon lived experiences with SMI to provide services to others with SMI in clinical settings. CoachToFit was shown to have high rates of acceptability and usability and was efficacious for weight loss in a small sample. VA has an opportunity to address obesity in the population with serious mental illness, currently a substantial gap in care.

Significance/Impact: 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.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Study Start: 2021-08-02
• Primary Completion: 2025-09-30
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-10
• Last Update Posted: 2025-10-14
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight control: Stages of change	Change from Baseline to 6 months and baseline to 12 months	Measures willingness and readiness to change eating and exercise patterns. 4 Yes/No items. The pattern of responses places an individual into one of four categories: precontemplation (lowest), contemplation, action, maintenance (highest)
EATING HABITS CONFIDENCE SURVEY	Change from Baseline to 6 months and baseline to 12 months	Measures a participants confidence in their eating habits and potential for change. 32 items. Scale is 1 to 5. Total score ranges from 32 to 160, with higher scores meaning more confidence in changing to healthy eating habits.
Measure Usability and Acceptability	6 month interview	Measures attitudes towards the Coach to fit intervention. 10 items. Scale is 1 = strongly disagree to 5 = strongly agree. After some calculations, total score ranges from 1- 100, with higher scores meaning more acceptability.
MOVE!11 Questionnaire	Change from Baseline to 6 months and baseline to 12 months	Measures attitudes toward eating habits and weight loss. 1 item on number of minutes spent in moderate physical activity per day. higher minutes means more activity.
Body weight.	Change from Baseline to 6 months and baseline to 12 months	Measurement of weight(in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States