Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.
BACKGROUND
The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese.


METHODS
The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial.


CONCLUSIONS
This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI.


BACKGROUND
www.clinicaltrials.gov; NCT02175641, registered 24 June 2014.
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. ljc2139@columbia.edu.
Leopoldo J
LJ
Cabassa
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. as2463@columbia.edu.
Ana
A
Stefancic
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. kmo2116@columbia.edu.
Kathleen
K
O'Hara
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. ne5@columbia.edu.
Nabila
N
El-Bassel
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA. Rlewis@nyspi.columbia.edu.
Roberto
R
Lewis-Fernández
Columbia University Medical Center, Presbyterian Hospital, 622 West 168th St, New York, NY, 10032, USA. jal94@cumc.columbia.edu.
José A
JA
Luchsinger
Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. lbg13@columbia.edu.
Lauren
L
Gates
New York Presbyterian, Family Medicine, 610 West 158th St, New York, NY, 10032, USA. rgy2013@columbia.edu.
Richard
R
Younge
New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY, 10032, USA. mmw2177@columbia.edu.
Melanie
M
Wall
Jefferson University Hospital, 833 Chestnut Street, Philadelphia, PA, 19107, USA. Lara.Weinstein@jefferson.edu.
Lara
L
Weinstein
University of Southern California School of Social Work, University Park, Los Angeles, CA, 90089, USA. palinkas@usc.edu.
Lawrence A
LA
Palinkas
D005260:Female; D016352:Group Homes; D015438:Health Behavior; D006798:Housing; D006801:Humans; D008019:Life Style; D008297:Male; D001523:Mental Disorders / Q000150:complications* / Q000175:diagnosis / Q000523:psychology; D009765:Obesity / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D010379:Peer Group; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome