Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT04560335
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:
NCT04560335
Study Brief:
Protocol Section:
NCT04560335