CoachToFit Weight Management for Serious Mental Illness
(C2F Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Dementia, Bariatric surgery, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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
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)
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Exclusion Criteria
Chart diagnosis of dementia
Pregnant and nursing mothers
Participants must complete the Physical Activity Readiness Questionnaire (PAR-Q)
See 4 more
Trial 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 (Behavioural Intervention)
- Treatment as Usual (Behavioural Intervention)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Evaluation of a behavioural weight management programme for patients with severe mental illness: 3 year results. [2008]Excess weight is a common problem in the general population and in those with severe mental illness and is associated with a range of adverse consequences. The evidence base for managing excess weight in those with severe psychiatric illness is small. We report the outcome of a weight management programme provided in a community mental health centre. The programme consisted of group sessions, held weekly and lasting one hour. Participants self-referred and attended as many sessions as they wished. Sessions included weighing, feedback from participants and education on a range of issues including healthy eating and exercise. Over a 3-year period 70 patients, predominantly with schizophrenia, attended the programme. Length of follow-up ranged from 2 weeks to 3 years. Data for all 70 patients was evaluated. The mean BMI at entry to the programme was 32.5 kg/m2. The mean number of sessions attended was 34. Patients achieved a mean weight loss of 4.97 kg. The mean BMI at last attendance was 30.7 kg/m2. Weight loss correlated with number of sessions attended (p = 0.0001). This study demonstrates the long-term value of a weight management programme at 3 years and supports the hypothesis that weight loss can be achieved using a simple behavioural intervention in motivated psychiatric patients.
Bringing an Effective Behavioral Weight Loss Intervention for People With Serious Mental Illness to Scale. [2020]People with serious mental illnesses (SMIs) die 10-20 years earlier than the general population, mainly due to cardiovascular disease. Obesity is a key driver of cardiovascular risk in this group. Because behavioral weight loss interventions tailored to the needs of people with SMI have been shown to lead to clinically significant weight loss, achieving widespread implementation of these interventions is a public health priority. In this Perspective, we consider strategies for scaling the ACHIEVE behavioral weight loss intervention for people with SMI, shown to be effective in a randomized clinical trial (RCT), to mental health programs in the U.S. and internationally. Given the barriers to high-fidelity implementation of the complex, multi-component ACHIEVE intervention in often under-resourced mental health programs, we posit that substantial additional work is needed to realize the full public health potential of this intervention for people with SMI. We discuss considerations for successful "scale-up," or efforts to expand ACHIEVE to similar settings and populations as those included in the RCT, and "scale-out," or efforts to expand the intervention to different mental health program settings/sub-populations with SMI. For both, we focus on considerations related (1) intervention adaptation and (2) implementation strategy development, highlighting four key domains of implementation strategies that we believe need to be developed and tested: staff capacity building, leadership engagement, organizational change, and policy strategies. We conclude with discussion of the types of future research needed to support ACHIEVE scale-up/out, including hybrid trial designs testing the effectiveness of intervention adaptations and/or implementations strategies.
Management of antipsychotic-induced weight gain: prospective naturalistic study of the effectiveness of a supervised exercise programme. [2009]To determine the potential effectiveness of a behavioural weight control programme including physical exercise in the prevention of antipsychotic-induced weight gain and associated comorbid conditions in outpatients with schizophrenia and mood disorders.
The effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders: results from a national multicentric study. [2019]To evaluate the effectiveness of a non-pharmacological intervention for weight gain management in severe mental disorders.
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]Obesity and metabolic disturbances frequently occur in individuals with psychiatric disorders. This study evaluates a telephonically delivered lifestyle coaching intervention aimed at weight reduction and wellness improvement in psychiatric outpatients. A cohort of 761 participants was prospectively followed up for a period of 12 months. Lifestyle coaching was administered telephonically on a weekly basis for the first 3 months and monthly thereafter. During the study period, there was a significant reduction in weight and waist circumference as well as a significant increase in general health in the completer group. A total of 46% of the participants lost 5% or more of their baseline weight. Significant predictors of attrition at baseline were the presence of metabolic syndrome, younger age, chronic illness, and the diagnosis of a mood disorder. Dropout was significantly less in those participants who received support from a nominated caregiver. Telephonic lifestyle coaching is feasible in this population.
Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. [2022]Effective and scalable interventions are needed to reach a greater proportion of individuals with serious mental illness (SMI) who experience alarmingly high rates of obesity. This pilot study evaluated the feasibility of translating an evidenced-based professional health coach model (In SHAPE) to peer health coaching for overweight and obese individuals with SMI. Key stakeholders collaborated to modify In SHAPE to include a transition from professional health coaching to individual and group-based peer health coaching enhanced by mobile health technology. Ten individuals with SMI were recruited from a public mental health agency to participate in a 6-month feasibility pilot study of the new model. There was no overall significant change in mean weight; however, over half (56 %) of participants lost weight by the end of the intervention with mean weight loss 2.7 ± 2.1 kg. Participants reported high satisfaction and perceived benefits from the program. Qualitative interviews with key stakeholders indicated that the intervention was implemented as planned. This formative research showed that peer health coaching for individuals with SMI is feasible. Further research is needed to evaluate its effectiveness.
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]The objective of this trial was to assess the long-term effect of the CHANGE lifestyle coaching intervention for 428 people with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. In this randomized, superiority, multi-center clinical trial, participants were randomized to 12 months of either lifestyle coaching plus care coordination (N = 138), care coordination alone, (N = 142) or treatment as usual (N = 148). There was no effect after 12 months, but we hypothesized that there might have been a delayed treatment effect. Our primary outcome at two-year follow-up was 10-year risk of cardiovascular disease standardized to 60 years of age. After two-years the mean 10-year cardiovascular-disease risk was 8.7% (95% confidence interval (CI) 7.6-9.9%) in the CHANGE group, 7.7% (95% CI 6.5-8.9%) in the care coordination group, and 8.9% (95% CI 6.9-9.2%) in the treatment as usual group (P = 0.24). Also, there were no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, weight, physical activity, diet and smoking. No reported adverse events could be ascribed to the intervention. We conclude that there was neither any direct nor any long-term effect of individual lifestyle coaching or care coordination on cardiovascular risk factors in people with abdominal obesity and schizophrenia spectrum disorders. The trial was approved by the Ethics Committee of Capitol Region Copenhagen, Denmark (registration number: H-4-2012-051) and the Danish Data Protection Agency (registration number: 01689 RHP-2012-007). The trial was funded by the Mental Health Services of the Capital Region of Denmark, the Lundbeck Foundation, the Tryg Foundation, the Danish Ministry of Health, and the Dæhnfeldts Foundation.
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]The rates of obesity and associated health problems are higher in people with serious mental illness (SMI), such as schizophrenia and bipolar disorder, than the general population. A primary care referral to a behavioural weight management programme can be an effective intervention, but people with SMI have reported barriers to engaging with them and bespoke options are rarely provided in routine practice. It is possible that adjunct support addressing these specific barriers could help. Here we report the development, feasibility and acceptability of an intervention to improve uptake and engagement with a mainstream weight management programme for people with SMI.
Improving Weight in People with Serious Mental Illness: The Effectiveness of Computerized Services with Peer Coaches. [2018]People with serious mental illness have high rates of obesity and related medical problems, and die years prematurely, most commonly from cardiovascular disease. Specialized, in-person weight management interventions result in weight loss in efficacy trials with highly motivated patients. In usual care, patient enrollment and retention are low with these interventions, and effectiveness has been inconsistent.
"MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. [2021]Veterans with serious mental illness are at increased risk of obesity, sedentary lifestyle, and a host of related chronic diseases. Although evidence suggests that lifestyle interventions can help mental health consumers achieve modest weight loss, several studies have failed to show a benefit and most have concluded that significant challenges remain in delivering effective interventions. In 2006, the Veterans Health Administration introduced MOVE!, a weight management program that includes behaviorally based dietary and physical activity self-management support. This article describes modifications used to manualize MOVE! for veterans with serious mental illness and reports findings from a randomized controlled trial of the new intervention.
Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. [2022]This study assessed phases one and two of a three-phase weight-loss program called RENEW--Recovering Energy Through Nutrition and Exercise for Weight Loss--among individuals with serious mental illness at four mental health centers. RENEW provides meal replacements twice daily and intensive instruction in nutrition and meal preparation, exercise, and goal setting for three months followed by three months of maintenance.