Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Thr

描述（由申请人提供）：我们的长期目标是减少肥胖和2型糖尿病（T2D）。我们提出的研究的直接目标是通过促进采用健康的生活方式来减少糖尿病的危险因素。在这个R-18提案中，我们计划通过基于信仰的活动和设置来评估一种生活方式干预的“有效性”和“成本效益”，即非裔美国人的健康身心（AAs）。健康的身体和灵魂使用“身体和灵魂”的研究方法，提供非常成功的临床基础上的“糖尿病预防计划”（DPP）的生活方式组成部分，该计划已被修改为小组参与。健康身体与灵魂计划将在AA教会与牧师和教会官员合作，并由DPP和身体与灵魂计划的专家指导。我们将观察拟议的干预措施是否对减少超重、缺乏运动和血糖升高（糖尿病的危险因素）有效。我们将重点关注AAs，这是一个有更多T2D和更多T2D风险因素的群体，包括更多的糖尿病前期、肥胖和缺乏运动。幸运的是，最近的临床试验表明，密集的生活方式改变计划可以“有效”地预防糖尿病干预的成人高风险的T2D。通过改善饮食行为和增加身体活动（PA），这些项目可以适度减轻体重，降低血糖，降低未来患糖尿病的风险。在这样的一项试验中，DPP是有效的——它使糖尿病发病率降低了58%。然而，它在社区环境中的有效性和可持续性需要进一步调查。我们提出的研究旨在填补这一空白。我们将在AA教会会众中实施健康身体和灵魂干预。这一战略符合让社区组织，特别是教会参与促进健康的日益增长的趋势。我们建议对超重的AA教会参与者进行集群随机社区试验（BMIe25）。这是基于我们之前在AA社区的研究，我们最近确定了20个渴望参与的AA教会，以及我们的初步研究结果。目的1：评估3个月Fit Body and Soul干预对T2D高危人群的有效性。目的2：确定Fit Body and Soul干预是否比对照组更具成本效益。根据cdc -社区指南，将提供当前可接受的、科学合理的健康教育方案。干预和控制项目都将由专家领导的教会健康顾问提供，并由教会牧师提供支持。主要结局是体重减轻（至少为基线体重的7%）。次要结果是PA增加（每周至少150分钟的中等强度运动），改善饮食选择，降低血糖（3mg/dL）。数据收集将在基线和干预后6个月和12个月进行。如果Fit Body and soul干预被发现是有效的，它将导致未来的有效性研究，以确定这种干预是否降低了T2D的发病率和相关的死亡率和发病率。研究表明，在医疗保健环境中，促进采用健康的生活方式，即包括最佳饮食和锻炼实践以及大量专家支持的生活方式，可以减少高危人群中2型糖尿病的发病率。在拟议的研究中，我们希望表明，在医疗保健领域之外的社区环境中（我们研究中的非洲裔美国人社区），相同或类似的计划是有效的。如果成功，我们的研究将为未来的有效性研究提供科学基础，我们将确定是否不仅是风险因素，而且糖尿病本身（及其相关的死亡率和发病率）可以通过行为生活方式计划（Fit Body and Soul）来减少，该计划已经根据社会文化信仰进行了修改。

DESCRIPTION (provided by applicant): 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.