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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coach to fit | Experimental | 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. |
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| Treatment as usual | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coach to FIt | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight. Mean Pounds | 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 |
| Body Weight. 5% Weight Loss | Number of Veterans who achieved 5% total weight loss at 6 months | Baseline to 6 months |
| Body Weight. 7% Total Weight Loss | Number of Veterans who achieved a 7% total weight loss by 6 months | Baseline to 6 months |
| BMI | Change in mean BMI from baseline to 6 months | Baseline to 6 months |
| 6 Minute Walk Test | How many meters a person can walk in 6 minutes. More is better | baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Chinman, PhD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41405896 | Result | Chinman M, Wang T, Dodge JR, Frank DA, McCoy JL, Cohen AN. Tailored Weight Loss Programs for Adults With Serious Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Feb 1;83(2):139-148. doi: 10.1001/jamapsychiatry.2025.3828. |
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Peer specialists, staff stakeholders, Veterans in local veteran groups, and/or national leadership were not considered enrolled.
We included adult Veterans (age ≥18) who had a chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with or without psychosis; a BMI ≥ 30.0 (obese); owned an Android or iPhone. Exclusion criteria included being pregnant or nursing, inpatient psychiatric hospitalization within ≤30 days, history of bariatric surgery, medical record diagnosis of dementia, or having a conservator/legally authorized representative make their medical decisions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 for six months. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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1 Veteran in the Treatment as Usual group was a screen failure, bringing that total to 128
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 for six months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight. Mean Pounds | Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better. | Analytic sample sizes varied. For weight, unadjusted analyses included 178 participants (93 CoachToFit, 85 Usual Care), while adjusted models included 173 participants (88 CoachToFit, 85 Usual Care) due to 5 missing baseline physical activity values. | Posted | Mean | Standard Deviation | Pounds | Change from Baseline to 6 months |
|
From baseline to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 for six months. |
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The study was at one VHA site and most participants had major depression, and thus future research should assess the generalizability to other populations beyond Veterans (i.e., older, male) with depression. Study data collectors were not able to be blinded, however, all the data collection was through fixed choice survey and objective measures, minimizing this limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Chinman, Research Career Scientist | Pittsburgh VA | 8184813909 | chinman@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2026 | Apr 13, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2024 | Jul 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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).
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| Treatment as Usual | Behavioral | 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 |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | All study activities were at the Pittsburgh VA | Count of Participants | Participants |
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| Diagnosis | This was diagnosis taken from the VA medical record | Count of Participants | Participants |
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| Psychosis | Psychosis was determined by the presence of any eligible diagnosis associated with psychosis at any of their appointments within three years from baseline assessment | Count of Participants | Participants |
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| Physical Activity | Number of minutes of exercise a day, on a day that they exercised, put into categories | There was missing data for 7 participants in the CoachToFit group | Count of Participants | Participants |
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| Use of Weight Loss Treatment, past 6 months | This documented whether or not a Veteran took a GLP-1 medication or participated in the VA's MOVE exercise program in the past 6 months | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | Body Weight. 5% Weight Loss | Number of Veterans who achieved 5% total weight loss at 6 months | Posted | Count of Participants | Participants | Baseline to 6 months |
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| Primary | Body Weight. 7% Total Weight Loss | Number of Veterans who achieved a 7% total weight loss by 6 months | Posted | Count of Participants | Participants | Baseline to 6 months |
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| Primary | BMI | Change in mean BMI from baseline to 6 months | Analytic sample sizes varied. For weight, unadjusted analyses included 178 participants (93 CoachToFit, 85 Usual Care), while adjusted models included 173 participants (88 CoachToFit, 85 Usual Care) due to 5 missing baseline physical activity values. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 6 months |
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| Primary | 6 Minute Walk Test | How many meters a person can walk in 6 minutes. More is better | This outcome had a different n due to missing data. | Posted | Mean | Standard Deviation | Meters walked in 6 minutes | baseline to 6 months |
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| 0 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | 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. | 0 | 129 | 0 | 129 | 0 | 129 |
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| D001519 | Behavior |
| 6 months |
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