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Open Access Highly Accessed Study protocol

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

Sarah S Casagrande1, Gerald J Jerome23, Arlene T Dalcin2, Faith B Dickerson4, Cheryl A Anderson15, Lawrence J Appel125, Jeanne Charleston5, Rosa M Crum11059, Deborah R Young9, Eliseo Guallar15, Kevin D Frick6, Richard W Goldberg78, Meghan Oefinger2, Joseph Finkelstein126, Joseph V Gennusa2, Oladapo Fred-Omojole2, Leslie M Campbell2, Nae-Yuh Wang12 and Gail L Daumit11011256*

Author Affiliations

1 Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, USA

2 Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

3 Department of Kinesiology, Towson University, Towson, Maryland, USA

4 Sheppard Pratt Health System, Towson, Maryland, USA

5 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

6 Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

7 VA Capitol Health Care Network (VISN 5) Mental Illness, Research, Education and Clinical Center, Baltimore, Maryland, USA

8 Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland, USA

9 Department of Epidemiology and Biostatistics, University of Maryland School of Public Health, College Park, Maryland, USA

10 Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

11 Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

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BMC Psychiatry 2010, 10:108  doi:10.1186/1471-244X-10-108

Published: 13 December 2010

Abstract

Background

Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group.

Methods/Design

A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months.

Discussion

Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.

Trial Registration

Clinical Trials.gov NCT00902694