Design of a Cluster-Randomized Controlled Trial of a Diabetes Prevention Program within African-American Churches: The Fit Body and Soul Study

• Type of Material: Article
• Authors: Lovoria B. Williams, Georgia Health Sciences University; Richard W. Sattin, Medical College of Georgia; James Dias, Medical College of Georgia; Jane T. Garvin, Georgia Health Sciences University; Lucy Marion, Georgia Health Sciences University; Thomas Joshua, Georgia Health Sciences University; Andrea Kriska, University of Pittsburgh; M. Kaye Kramer, University of Pittsburgh; Justin B. Echouffo-Tcheugui, Emory University; Arin Freeman, Georgia Health Sciences University; K.M. Venkat Narayan, Emory University
• Language: English
• Date: 2013-03
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2012 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2013.01.002
• Title of Journal or Parent Work: Contemporary Clinical Trials
• ISSN: 1551-7144
• Volume: 34
• Issue: 2
• Start Page: 336
• End Page: 347
• Grant/Funding Information: Funded by the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, grant R18DK082401.
• Keywords: cluster; diabetes prevention; church; obesity; translation research; African-American
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Public Health

Abstract

Evidence from varied community settings has shown that the Group Lifestyle Balance (GLB) Program and other adaptations of the Diabetes Prevention Program (DPP) intervention are effective in lowering diabetes risk. Most DPP data originated from studies of pre-diabetic whites, with only sparse evidence of the effect of DPP in African Americans (AAs) in community settings. This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul (FBAS). The major aims are to test efficacy and cost utility of FBAS in twenty AA churches. Randomization occurred at the church level and 604 AA overweight/obese (BMI≥25 kg/m2) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program. FBAS is a group-based, multi-level intervention delivered by trained church health advisors (health professionals from within the church), with the goal of ≥7% weight loss, achieved through increasing physical activity, healthy eating and behavior modification. The primary outcome is weight change at 12-weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination.