257 Participants Needed

CoachToFit Weight Management for Serious Mental Illness

(C2F Trial)

RM
MJ
RM
JR
Overseen ByJessica R Dodge, PhD MSW MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Coach to Fit treatment for weight management in individuals with serious mental illness?

Research shows that behavioral weight management programs, including group sessions and telephonic lifestyle coaching, can lead to significant weight loss and improved health in people with serious mental illness. These programs often involve education on healthy eating and exercise, and their success is linked to regular participation and support from caregivers.12345

Is the CoachToFit Weight Management program safe for people with serious mental illness?

The studies on lifestyle coaching interventions for weight management in people with serious mental illness did not report any safety concerns or adverse events related to the interventions. Participants generally found the programs feasible and beneficial, suggesting they are safe for use in this population.15678

How is the CoachToFit treatment different from other weight management treatments for serious mental illness?

CoachToFit is unique because it uses peer health coaching, where individuals with similar experiences support each other, enhanced by mobile health technology. This approach differs from traditional professional health coaching and aims to be more relatable and accessible for people with serious mental illness.1691011

Research Team

MJ

Matthew J. Chinman, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychosis.
Your body mass index (BMI) is 30.0 or higher, which means you are considered obese.
Ownership of a phone running Android OS or iOS (iPhone)

Exclusion Criteria

Chart diagnosis of dementia
Pregnant and nursing mothers
Participants must complete the Physical Activity Readiness Questionnaire (PAR-Q)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the CoachToFit app with weekly telephonic support from a VA peer specialist, complete modules, and engage in coaching calls

6 months
Weekly telephonic support

Follow-up

Participants are monitored for changes in eating habits, usability, acceptability, and body weight

6 months

Treatment Details

Interventions

  • Coach to Fit
  • Treatment as Usual
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

A community weight management program for patients with severe mental illness, primarily schizophrenia, led to a significant average weight loss of 4.97 kg over a 3-year period, with participants attending an average of 34 sessions.
The study highlights that increased attendance in the program was strongly correlated with greater weight loss, suggesting that consistent participation in behavioral interventions can effectively support weight management in motivated psychiatric patients.
Evaluation of a behavioural weight management programme for patients with severe mental illness: 3 year results.Pendlebury, J., Haddad, P., Dursun, S.[2008]
People with serious mental illnesses (SMIs) face a higher risk of early death due to cardiovascular disease, with obesity being a major contributing factor, highlighting the need for effective weight loss interventions.
The ACHIEVE behavioral weight loss intervention has shown significant effectiveness in a randomized clinical trial, but scaling it up to broader mental health programs requires addressing challenges in implementation, including staff training and organizational support.
Bringing an Effective Behavioral Weight Loss Intervention for People With Serious Mental Illness to Scale.McGinty, EE., Gudzune, KA., Dalcin, A., et al.[2020]
In a study of 110 outpatients with schizophrenia and mood disorders, a behavioral weight control program that included exercise led to significant weight loss and improved metabolic health over 18 months, while the control group experienced weight gain and worsening metabolic profiles.
The active group showed reductions in body weight, BMI, waist circumference, and improvements in cholesterol and glucose levels, demonstrating that structured physical activity can effectively counteract antipsychotic-induced weight gain and associated health risks.
Management of antipsychotic-induced weight gain: prospective naturalistic study of the effectiveness of a supervised exercise programme.Poulin, MJ., Chaput, JP., Simard, V., et al.[2009]

References

Evaluation of a behavioural weight management programme for patients with severe mental illness: 3 year results. [2008]
Bringing an Effective Behavioral Weight Loss Intervention for People With Serious Mental Illness to Scale. [2020]
Management of antipsychotic-induced weight gain: prospective naturalistic study of the effectiveness of a supervised exercise programme. [2009]
The effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders: results from a national multicentric study. [2019]
The evaluation of a telephonic wellness coaching intervention for weight reduction and wellness improvement in a community-based cohort of persons with serious mental illness. [2022]
Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. [2022]
Effect of lifestyle coaching versus care coordination versus treatment as usual in people with severe mental illness and overweight: Two-years follow-up of the randomized CHANGE trial. [2018]
Development and initial evaluation of a behavioural intervention to support weight management for people with serious mental illness: an uncontrolled feasibility and acceptability study. [2023]
Improving Weight in People with Serious Mental Illness: The Effectiveness of Computerized Services with Peer Coaches. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
"MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. [2022]