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Contemp Clin Trials. 2018 Nov;74:97-106. doi: 10.1016/j.cct.2018.10.005. Epub 2018 Oct 11.

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

Author information

1
Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States; The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States. Electronic address: Kelly.A.Aschbrenner@Dartmouth.edu.
2
Department of Global Health and Social Medicine, Harvard Medical School, United States.
3
Department of Psychology, University of Connecticut, Storrs, CT, United States.
4
Department of Occupational Therapy, Boston University, Boston, MA, United States.
5
Biomedical Data Sciences, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States; Department of Community and Family Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States.
6
Department of Psychiatry, Harvard Medical School, Boston, MA, United States.
7
The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, United States.
8
The Mongan Institute, Massachusetts General Hospital, Cambridge, MA, United States.

Abstract

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.

KEYWORDS:

Lifestyle intervention; Mobile health technology; Peer support; Serious mental illness; Young adult

PMID:
30316998
PMCID:
PMC6217796
[Available on 2019-11-01]
DOI:
10.1016/j.cct.2018.10.005

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