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

Serious Mental Illness Clinical Trial

— C2F  

Official title:

CoachToFit: Adapted Weight Loss Intervention for Individuals With Serious Mental Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560335
• Other study ID #: IIR 19-153
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Jessica R Dodge, PhD MSW MPH
• Phone: (734) 845-3609
• Email: Jessica.Dodge[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Serious Mental Illness
• Weight Loss

Intervention

Behavioral:
• Coach to FIt
CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about 15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly.
• Treatment as Usual
Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EATING HABITS CONFIDENCE SURVEY	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.	Change from Baseline to 6 months and baseline to 12 months
Primary	Measure Usability and Acceptability	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.	6 month interview
Primary	MOVE!11 Questionnaire	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.	Change from Baseline to 6 months and baseline to 12 months
Primary	Weight control: Stages of change	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)	Change from Baseline to 6 months and baseline to 12 months
Primary	Body weight.	Measurement of weight(in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.	Change from Baseline to 6 months and baseline to 12 months