CoachToFit Weight Management for Serious Mental Illness

(C2F Trial)

Overseen By Jessica R Dodge, PhD MSW MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Bariatric surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

257 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 6 9 10 11}

Research Team

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)

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

Group I: Treatment as usual Experimental Treatment 1 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 fit Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 1,071 patients with severe mental disorders, a 12-week group intervention focusing on nutrition, lifestyle, and physical activity led to significant weight loss and BMI reduction, indicating its effectiveness in managing weight gain.

The intervention also resulted in a notable increase in physical activity among participants, with 70.8% engaging in more exercise after the program, suggesting improvements in overall health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders: results from a national multicentric study. Attux, C., Martini, LC., Araújo, CM., et al.[2019]

A telephonic lifestyle coaching intervention for psychiatric outpatients led to significant weight loss and improved health over 12 months, with 46% of participants losing 5% or more of their baseline weight.

The study found that having support from a caregiver reduced dropout rates, highlighting the importance of social support in maintaining participation in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Temmingh, H., Claassen, A., van Zyl, S., et al.[2022]

A pilot study involving 10 individuals with serious mental illness (SMI) tested a peer health coaching model for weight management over 6 months, showing that 56% of participants lost weight, with an average loss of 2.7 kg.

Participants expressed high satisfaction with the program, indicating that peer health coaching is a feasible approach for addressing obesity in individuals with SMI, although further research is needed to assess its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. Aschbrenner, KA., Naslund, JA., Barre, LK., et al.[2022]

In a study involving 428 participants with abdominal obesity and schizophrenia spectrum disorders, a 12-month lifestyle coaching intervention showed no significant impact on cardiovascular risk after two years, with similar risk levels across all treatment groups.

No adverse events were reported related to the intervention, indicating that while the lifestyle coaching did not improve health outcomes, it was safe for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jakobsen, AS., Speyer, H., Nørgaard, HCB., et al.[2018]

The 'Weight cHange for people with sErious mEntal iLlness' (WHEEL) intervention, which included a mainstream weight management program and adjunct support, showed high acceptability and engagement among participants with serious mental illness, with a retention rate of 94%.

Participants experienced a mean weight loss of 4.1 kg over 12 weeks, indicating that the intervention was not only feasible but also effective in promoting weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial evaluation of a behavioural intervention to support weight management for people with serious mental illness: an uncontrolled feasibility and acceptability study. Lee, C., Waite, F., Piernas, C., et al.[2023]

A study involving 276 overweight patients with serious mental illness found that a computerized weight management program with peer coaching (WebMOVE) led to a significant average weight loss of 2.8 kg (6.2 lbs) over 6 months, while in-person services and usual care showed no significant changes in weight.

The WebMOVE program was well accepted by participants, suggesting it could be a feasible and effective alternative to traditional in-person weight management interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Weight in People with Serious Mental Illness: The Effectiveness of Computerized Services with Peer Coaches. Young, AS., Cohen, AN., Goldberg, R., et al.[2018]

A randomized controlled trial involving 109 overweight or obese veterans with serious mental illness found that the MOVE! weight management program did not lead to significant weight loss compared to a control group that received basic diet and exercise information.

Only a small number of participants (seven) achieved a 5% weight loss, and there were no significant differences in metabolic, dietary, or physical activity measures between the MOVE! group and the control group after six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. Goldberg, RW., Reeves, G., Tapscott, S., et al.[2021]

The RENEW weight-loss program, which includes meal replacements and intensive nutrition and exercise instruction, led to significant weight loss in individuals with serious mental illness, with participants losing an average of 5.3 pounds at three months and 4.4 pounds at six months.

Participants in the control group experienced minimal weight changes, highlighting the effectiveness of the RENEW program in promoting weight loss regardless of the type of psychiatric medication taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. Brown, C., Goetz, J., Hamera, E.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a behavioural weight management programme for patients with severe mental illness: 3 year results. [2008]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bringing an Effective Behavioral Weight Loss Intervention for People With Serious Mental Illness to Scale. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Management of antipsychotic-induced weight gain: prospective naturalistic study of the effectiveness of a supervised exercise programme. [2009]

4. Brazil pubmed.ncbi.nlm.nih.gov

The effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders: results from a national multicentric study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Improving Weight in People with Serious Mental Illness: The Effectiveness of Computerized Services with Peer Coaches. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

"MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. [2022]