Serious Mental IllnessC2FNCT04560335

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

A study testing Coach to FIt and Treatment as Usual in people with Serious Mental Illness, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Serious Mental Illness
What is being tested?: Coach to FIt and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2021to 31 Mar 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Serious Mental Illness
Being tested: Coach to FIt, Treatment as Usual
Keywords: weight loss, mental illness, exercise
Medical subject headings: Weight Loss, Mental Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coach to FItBehavioural
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 UsualBehavioural
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

Study groups in NCT04560335
Study group	Role	What they receive
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. Receives: Behavioral: Coach to FIt
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 Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight. Mean Pounds
Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.
Measured: Change from Baseline to 6 months
Body Weight. 5% Weight Loss
Number of Veterans who achieved 5% total weight loss at 6 months
Measured: Baseline to 6 months
Body Weight. 7% Total Weight Loss
Number of Veterans who achieved a 7% total weight loss by 6 months
Measured: Baseline to 6 months
BMI
Change in mean BMI from baseline to 6 months
Measured: Baseline to 6 months
6 Minute Walk Test
How many meters a person can walk in 6 minutes. More is better
Measured: baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202131 Mar 2026

First posted23 Sep 2020
Study start2 Aug 2021
Primary completion30 Sep 2025
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04560335
Sponsor's protocol ID: IIR 19-153
Acronym: C2F
Status last verified: May 2026
First submitted: 16 Sep 2020
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41405896

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CoachToFit: Adapted Weight Loss Intervention for Individuals With Serious Mental Illness
ClinicalTrials.gov ID: NCT04560335
Acronym / sponsor ID: C2F / IIR 19-153
Conditions: Serious Mental Illness
Keywords: weight loss, mental illness, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 2 Aug 2021 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 23 Sep 2020 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Coach to fit	Experimental	Behavioral: Coach to FItCoachToFit: 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	Other	Behavioral: Treatment as UsualVeterans 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coach to FItCoachToFit: 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.	Behavioural	Coach to fit
Treatment as UsualVeterans 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	Behavioural	Treatment as usual

Primary outcome

Body Weight. Mean Pounds
Time frame: Change from Baseline to 6 months
Measurement of weight (in pounds) will be obtained for all participants using a hospital quality scale. Less pounds is better.
Body Weight. 5% Weight Loss
Time frame: Baseline to 6 months
Number of Veterans who achieved 5% total weight loss at 6 months
Body Weight. 7% Total Weight Loss
Time frame: Baseline to 6 months
Number of Veterans who achieved a 7% total weight loss by 6 months
BMI
Time frame: Baseline to 6 months
Change in mean BMI from baseline to 6 months
6 Minute Walk Test
Time frame: baseline to 6 months
How many meters a person can walk in 6 minutes. More is better

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coach to Fit	128	93
Treatment as Usual	129	85

Primary outcome: Body Weight. Mean Pounds

Time frame: Change from Baseline to 6 months. Mean (Standard Deviation). Unit: Pounds

Measure	Coach to Fit n = 93	Treatment as Usual n = 85
Baseline	244.3 (46.7)	252.2 (45.8)
6 months	237.2 (46.5)	246.7 (43.4)

Coach to Fit vs Treatment as Usual: Mean Difference (Net): -3.57, p = 0.05, ANCOVA

Population analysed: 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.

Primary outcome: Body Weight. 5% Weight Loss

Time frame: Baseline to 6 months. Count of participants. Unit: Participants

Measure	Coach to Fit n = 88	Treatment as Usual n = 85
Value	34	19

Coach to Fit vs Treatment as Usual: Odds Ratio (OR): 1.93 (95% CI .96 to 3.91), p = 0.038, Regression, Logistic

Primary outcome: Body Weight. 7% Total Weight Loss

Time frame: Baseline to 6 months. Count of participants. Unit: Participants

Measure	Coach to Fit n = 88	Treatment as Usual n = 85
Value	21	7

Coach to Fit vs Treatment as Usual: Odds Ratio (OR): 3.87 (95% CI 1.45 to 10.36), p = 0.009, Regression, Logistic

Primary outcome: BMI

Time frame: Baseline to 6 months. Mean (Standard Deviation). Unit: kg/m^2

Measure	Coach to Fit n = 93	Treatment as Usual n = 85
Baseline	36.4 (5.4)	37.0 (5.4)
6 months	35.3 (5.5)	36.5 (5.2)

Coach to Fit vs Treatment as Usual: Mean Difference (Net): -.56 (95% CI -1.15 to .03), p = 0.04, ANCOVA

Adverse events

Time frame: From baseline to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coach to Fit	0 of 128 (0%)	0 of 128 (0%)	0 of 128
Treatment as Usual	0 of 129 (0%)	0 of 129 (0%)	0 of 129

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41405896Chinman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew J Chinman, PhD principal investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coach to FIt and Treatment as Usual in people with Serious Mental Illness, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight. Mean Pounds (time frame: Change from Baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.