Clinical trial NCT04560335: Coach to Fit Weight Loss Intervention for Individuals With Serious Mental Illness
Official title: CoachToFit: Adapted Weight Loss Intervention for Individuals With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Keywords: weight loss
mental illness
exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-23
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Methodology: The study design includes a randomized controlled trial to test the efficacy of CoachToFit and assess the hypothesized mechanisms of action. This will include enrollment of obese Veterans with SMI from the mental health clinics at one VA medical center (n=256). Individuals will be randomized to CoachToFit or usual care. Those in CoachToFit will have access to the app and coaching for 6 months. Outcomes are assessed at 6- and 12-months. Efficacy outcomes utilize objective measures. The design also includes a multi- stakeholder qualitative post-intervention evaluation guided by the RE-AIM framework to characterize factors that will inform future implementation and maintenance of CoachToFit. This will include interviews with Veterans randomized to CoachToFit (n=30); interviews with staff stakeholders (n=18); a discussion with Veterans in local Veteran groups (n=2 groups; n=11 Veterans), and interviews with national leadership (n=3).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EATING HABITS CONFIDENCE SURVEY
timeFrame: Change from Baseline to 6 months and baseline to 12 months
measure: Measure Usability and Acceptability
timeFrame: 6 month interview
measure: MOVE!11 Questionnaire
timeFrame: Change from Baseline to 6 months and baseline to 12 months
measure: Weight control: Stages of change
timeFrame: Change from Baseline to 6 months and baseline to 12 months
measure: Body weight.
timeFrame: Change from Baseline to 6 months and baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Matthew J. Chinman, PhD
role: PRINCIPAL_INVESTIGATOR
References: