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CoachToFit Weight Management for Serious Mental Illness (C2F Trial)

Phase 3
Recruiting
Led By Matthew J. Chinman, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis
Age 18 and over
Must not have
Patient has a conservator/legally authorized representative who makes their medical decisions
History of bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 months and baseline to 12 months
Awards & highlights

Summary

This trial will evaluate the efficacy of CoachToFit, 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.

Who is the study for?
This trial is for adults with a BMI of 30 or higher who have been diagnosed with serious mental illnesses like schizophrenia, bipolar disorder, or major depression with psychosis. They must own a smartphone and not have dementia, recent bariatric surgery, current pregnancy or nursing status, recent psychiatric hospitalization, or require medical decision-making by a conservator.
What is being tested?
The study compares the 'Coach to Fit' weight management program that uses mobile technology and real-time data visualization against the usual treatment methods. It aims to help individuals with serious mental illness (SMI) lose weight in an innovative way that's easy to adopt within the healthcare system.
What are the potential side effects?
Since this intervention involves lifestyle changes through coaching rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but are generally minimal compared to pharmacological treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychosis.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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Someone legally makes medical decisions for me.
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I have had weight loss surgery in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 6 months and baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 months and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body weight.
EATING HABITS CONFIDENCE SURVEY
MOVE!11 Questionnaire
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment1 Intervention
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
Group II: Coach to fitExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment as Usual
2016
Completed Phase 3
~2710

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,810 Total Patients Enrolled
4 Trials studying Serious Mental Illness
637 Patients Enrolled for Serious Mental Illness
Matthew J. Chinman, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
5 Previous Clinical Trials
6,397 Total Patients Enrolled
1 Trials studying Serious Mental Illness
252 Patients Enrolled for Serious Mental Illness

Media Library

Coach to Fit Clinical Trial Eligibility Overview. Trial Name: NCT04560335 — Phase 3
Serious Mental Illness Research Study Groups: Treatment as usual, Coach to fit
Serious Mental Illness Clinical Trial 2023: Coach to Fit Highlights & Side Effects. Trial Name: NCT04560335 — Phase 3
Coach to Fit 2023 Treatment Timeline for Medical Study. Trial Name: NCT04560335 — Phase 3
~64 spots leftby Sep 2025
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