Our long-term goal is to reduce obesity &type 2 diabetes (T2D). The immediate goal of our proposed study is to reduce diabetes risk factors by promoting the adoption of healthy lifestyles. In this R-18 proposal, we plan to assess the "effectiveness" and "cost-effectiveness" of a lifestyle intervention, the Fit Body and Soul for African Americans (AAs) through faith-based activities and settings. The Fit Body and Soul uses "Body and Soul" study approaches to deliver the lifestyle component of the highly successful clinically based "Diabetes Prevention Program" (DPP) which has been modified with group participation. The Fit body and Soul program will be offered in AA churches in partnership with their pastors and church officials along with guidance from experts from both DPP and Body and Soul programs. We will see if the proposed intervention is effective in reducing excess weight, physical inactivity, and elevated blood sugar (risk factors for T2D). We will focus on AAs, a group with more T2D and more T2D risk factors including more pre-diabetes, obesity and physical inactivity. Fortunately, recent clinical trials have shown that intensive lifestyle modification programs can be "efficacious" diabetes prevention interventions for adults at high risk for T2D. Through improving dietary behaviors and increasing physical activity (PA), these programs lead to modest weight loss, lowered blood sugar and reduce future risk of T2D. One such trial, the DPP was efficacious - it led to a 58% reduction in diabetes. However, its effectiveness &sustainability in a community setting needs further investigation. Our proposed study is designed to fill this gap. We will implement the Fit Body and soul intervention in AA church congregations. This strategy is consistent with a growing trend to involve community organizations, especially churches, in health promotion. We propose a cluster randomized community trial of AA church participants who are overweight (BMIe25). This builds on our previous research in the AA community, our recent identification of 20 AA churches eager to participate, and on our pilot study results.
Aim 1 : To assess the effectiveness of a 3-month Fit Body and Soul intervention for those at high risk for T2D.
Aim 2 : To determine if the Fit Body and Soul intervention is more cost-effective than control arm. Controls will be given currently acceptable and scientifically sound health education programs, derived from the CDC-Community Guide. Both intervention and control programs will be delivered by expert-led church health advisors and supported by church pastors. The primary outcome is weight loss (at least 7% of baseline body weight). Secondary outcomes are increased PA (at least 150 minutes of moderate intensity exercise/ week) improved dietary choices, and reduction in blood sugar (e3mg/dL). Data collection will be done at baseline and 6 &12 months post-intervention. If the Fit Body and soul intervention is found effective, it would lead to a future effectiveness study that would determine whether this intervention reduces the incidence of T2D and the associated mortality and morbidity. Project Narrative It has been shown that promoting the adoption of healthy lifestyles, ones that involve best practices of diet and exercise and lots of expert support, can, in a healthcare setting, reduce the incidence of type 2 diabetes in those who are at high risk. In the proposed study, we hope to show that the same or similar programs are effective in the community setting (African American communities in our study), outside of the healthcare arena. If successful, our study would provide a scientific basis for a future effectiveness study in which we would determine whether not just risk factors but diabetes itself (and its associated mortality and morbidity) can be reduced with behavioral lifestyle program (Fit Body and Soul) that has been modified for social cultural faith-based settings.
|Williams, Lovoria B; Sattin, Richard W; Dias, James et al. (2013) Design of a cluster-randomized controlled trial of a diabetes prevention program within African-American churches: The Fit Body and Soul study. Contemp Clin Trials 34:336-47|