Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study

Lovoria B. Williams, Richard Warren Sattin, James Dias, Barbara Jane Threatt Garvin, Lucy Nelle Marion, Thomas Vayalinkara Joshua, Andrea Kriska, M. Kaye Kramer, Justin B. Echouffo-Tcheugui, Arin Freeman, K. M. Venkat Narayan

Research output: Contribution to journalArticle

28 Citations (Scopus)

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≥25kg/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 12weeks 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.

Original languageEnglish (US)
Pages (from-to)336-347
Number of pages12
JournalContemporary Clinical Trials
Volume34
Issue number2
DOIs
StatePublished - Mar 1 2013

Fingerprint

African Americans
Randomized Controlled Trials
Costs and Cost Analysis
Life Style
Fasting
Health
Exercise
Glucose
Behavior Therapy
Program Evaluation
Waist Circumference
Feeding Behavior
Random Allocation
Health Education
Cost-Benefit Analysis
Weight Loss
Reference Values
Hemoglobins
Quality of Life
Blood Pressure

Keywords

  • African-American
  • Church
  • Cluster
  • Diabetes prevention
  • Obesity
  • Translation research

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches : The Fit Body and Soul study. / Williams, Lovoria B.; Sattin, Richard Warren; Dias, James; Garvin, Barbara Jane Threatt; Marion, Lucy Nelle; Joshua, Thomas Vayalinkara; Kriska, Andrea; Kramer, M. Kaye; Echouffo-Tcheugui, Justin B.; Freeman, Arin; Venkat Narayan, K. M.

In: Contemporary Clinical Trials, Vol. 34, No. 2, 01.03.2013, p. 336-347.

Research output: Contribution to journalArticle

Williams, LB, Sattin, RW, Dias, J, Garvin, BJT, Marion, LN, Joshua, TV, Kriska, A, Kramer, MK, Echouffo-Tcheugui, JB, Freeman, A & Venkat Narayan, KM 2013, 'Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study', Contemporary Clinical Trials, vol. 34, no. 2, pp. 336-347. https://doi.org/10.1016/j.cct.2013.01.002
Williams, Lovoria B. ; Sattin, Richard Warren ; Dias, James ; Garvin, Barbara Jane Threatt ; Marion, Lucy Nelle ; Joshua, Thomas Vayalinkara ; Kriska, Andrea ; Kramer, M. Kaye ; Echouffo-Tcheugui, Justin B. ; Freeman, Arin ; Venkat Narayan, K. M. / Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches : The Fit Body and Soul study. In: Contemporary Clinical Trials. 2013 ; Vol. 34, No. 2. pp. 336-347.
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