CoachToFit Weight Management for Serious Mental Illness

(C2F Trial)

Overseen By Jessica R Dodge, PhD MSW MPH

Age: 18+

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with serious mental illnesses, such as schizophrenia or bipolar disorder, manage obesity through a new mobile app called CoachToFit. The app leverages technology to simplify weight management, featuring tools like an activity tracker and a Bluetooth scale. Participants will collaborate with a peer coach and use the app to set goals and monitor progress. Suitable candidates have a BMI of 30 or more, own a smartphone, and do not have conditions like dementia or a history of bariatric surgery. As an unphased trial, this study provides a unique opportunity to explore innovative weight management solutions tailored to participants' needs.

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 prior data suggests that the CoachToFit program is safe for individuals with serious mental illness?

Research has shown that the CoachToFit program, designed to help individuals with serious mental illness (SMI) manage their weight, is safe. Earlier studies found no safety issues or negative effects. Participants appreciated the program, and it aided weight loss in a small group. The mobile app and coaching method are user-friendly and appealing, encouraging participation without risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CoachToFit program for weight management in individuals with serious mental illness because it integrates technology and personalized coaching in a novel way. Unlike traditional weight management strategies that might only involve in-person sessions or general advice, CoachToFit uses a mobile app combined with an activity tracker and Bluetooth scale to provide a more interactive and engaging experience. This approach not only helps participants track their progress in real-time but also encourages them to set and achieve personalized goals with the help of a peer coach. This blend of digital tools and personal support makes it a promising option for enhancing motivation and adherence to weight management plans.

What evidence suggests that the CoachToFit program is effective for weight management in individuals with serious mental illness?

Research has shown that the CoachToFit program, which participants in this trial may receive, helps people with serious mental illness (SMI) lose weight. In a past study, participants using CoachToFit lost an average of about 5 kg. Users rated this weight loss program highly for its user-friendly design. The program employs mobile technology and real-time data to help participants track their progress. These features aim to make weight management easier and more sustainable for people with SMI. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew J. Chinman, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04560335?term=AREA%5BConditionSearch%5D(Seriousness)&rank=7

Coach to Fit Weight Loss Intervention for Individuals With ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/234206/coach-to-fit-weight-loss-intervention-for-individuals-with-serious-mental-illness/

Coach to Fit Weight Loss Intervention for Individuals With ... 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 ...

3. withpower.com withpower.com/trial/phase-3-mental-disorders-7-2021-33db7

CoachToFit Weight Management for Serious Mental Illness ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8952200/

Identifying effective characteristics of behavioral weight ... People with serious mental illness (SMI) have identified barriers to engaging in behavioral weight management interventions (BWMIs).

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2014.14030357

Pragmatic Replication Trial of Health Promotion Coaching ... Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611674/

Impact of Online Weight Management with Peer Coaching ... Impact of online weight management with peer coaching on physical activity levels of adults with serious mental illness.

7. hsrd.research.va.gov hsrd.research.va.gov/publications/vets_perspectives/0120-Mobile-App-for-Weight-Management-Designed-by-and-for-Veterans-with-Serious-Mental-Illness.cfm

Mobile App for Weight Management Designed by and for ... Introduction: The CoachToFit tool delivers the MOVE! program to obese Veterans with comorbid serious mental illness (SMI) via a mobile app.