Translational research principles of an effectiveness trial for diabetes care in an urban African American population

Purpose: Large-scale effectiveness trials designed to translate evidence-based diabetes care to community settings are few. Studies describing these methods among high-risk minority populations are particularly limited. Methods: The authors describe Project Sugar, a randomized controlled trial conducted in 2 phases: Project Sugar 1 (1994-1999), which piloted a 4-arm clinic and homebased intervention using nurse case management and community health workers in 186 urban African Americans with type 2 diabetes, and Project Sugar 2 (2000-2005), which examined effectiveness of this intervention among 542 diabetic, urban African Americans. Results and Conclusions: Project Sugar had success with regard to recruitment and retention, both in phase 1 (80% rate at 24 months) and phase 2 (>90% at 24 months). Using the RE-AIM framework, planning and research design for Project Sugar 2 is described in detail for elements that contributed to the reach, effectiveness, adoption, implementation, and maintenance of this study within a minority community setting. In addition to successful strategies, challenges to conducting effectiveness trials in an inner-city African American community are identified.