Peer support and mobile health technology targeting obesity-related cardiovascular risk in young adults with serious mental illness: Protocol for a randomized controlled trial

Background Individuals with serious mental illness (SMI) such as schizophrenia and bipolar disorder face a higher risk of early death due to cardiovascular disease and other preventable chronic illnesses. Young adulthood is a critical window of development for lifestyle interventions to improve the long-term health and quality of life in this population. Fit Forward is an NIH-funded randomized clinical trial examining the effectiveness of a group lifestyle intervention (PeerFIT) enhanced with mobile health technology compared to one-on-one mobile lifestyle coaching with Basic Education in fitness and nutrition supported by a wearable Activity Tracking device (BEAT) in achieving clinically significant weight loss and improved cardiorespiratory fitness in young adults with SMI. Methods Fit Forward targets 144 young adults (18 to 35 years) with SMI and a body mass index (BMI) of ≥25 receiving public mental health services. In a two-arm randomized clinical trial, participants will be randomly assigned with equal probability to PeerFIT or BEAT, stratified by birth sex and psychiatric diagnosis. Participants will be assessed at baseline, 6, and 12 months. The primary outcome is cardiovascular risk reduction indicated by either clinically significant weight loss (5% or greater) or increased fitness (>50 m on the 6-Minute Walk Test). Secondary outcomes include change in BMI, lipids, and hemoglobin A1c. Perceived self-efficacy for exercise and peer support will be evaluated as mechanisms underlying intervention effects. Conclusion If effective, PeerFIT will provide a potentially scalable approach to addressing health risks among young adults with SMI in mental health settings. Trials registration ClinicalTrials.gov, NCT02815813 .