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

身心健康：预防糖尿病的生活方式干预措施

• 批准号: 7560284
• 负责人: Frank A Treiber
• 金额: $ 61.34万
• 依托单位: AUGUSTA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7560284
• 关键词: Adopted; Adoption; Adult; African American; Age; American; Area; Behavior; Behavioral; Blood Glucose; Body Weight; Body Weight decreased; Cessation of life; Chronic Disease; Church; Clinical Trials; Communities; Community Trial; Costs and Benefits; Data Collection; Development; Diabetes Mellitus; Diabetes prevention; Effectiveness; Effectiveness of Interventions; Elements; Epidemic; Equilibrium; Ethnic group; Exercise; Fasting; Funding; Future; Gender; Goals; Health; Health Promotion; Health education; Healthcare; Incidence; Individual; Institutes; Intervention; Investigation; Kidney Diseases; Lead; Life Style; Measures; Minority Groups; Modeling; Modification; Morbidity - disease rate; Multi-Institutional Clinical Trial; Non-Insulin-Dependent Diabetes Mellitus; Numbers; Obesity; Outcome; Overweight; Participant; Physical activity; Pilot Projects; Prevalence; Prevention; Prevention intervention; Purpose; Randomized; Randomized Controlled Clinical Trials; Range; Rate; Relative (related person); Research; Research Personnel; Risk; Risk Factors; Testing; Training; Training Support; Translating; United States; United States National Institutes of Health; Upper arm; Walking; Week; Weight; Work; aged; base; behavior change; behavioral/social science; community organizations; cost; cost effectiveness; design; diabetes prevention program; diabetes risk; diet and exercise; efficacy trial; health disparity; improved; intervention program; lifestyle intervention; mortality; nutrition; opportunity cost; programs; social; sound; statistics; success; trend

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.

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健康的生活方式来减少糖尿病危险因素。在这份 R-18 提案中，我们计划评估生活方式干预的“有效性”和“成本效益”，即通过基于信仰的活动和环境为非裔美国人 (AA) 打造健康的身体和灵魂。 Fit Body and Soul 使用“身体与灵魂”研究方法来提供非常成功的基于临床的“糖尿病预防计划”(DPP) 的生活方式部分，该计划已通过团体参与进行了修改。 AA 教会将与其牧师和教会官员合作，在 DPP 和身体与灵魂计划专家的指导下提供健身身体与灵魂计划。我们将看看所提出的干预措施是否能有效减少体重过重、缺乏身体活动和血糖升高（T2D 的危险因素）。我们将重点关注 AA 人群，该群体具有更多的 T2D 和更多的 T2D 危险因素，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，强化生活方式改变计划可以成为 T2D 高危成人的“有效”糖尿病预防干预措施。通过改善饮食行为和增加体力活动 (PA)，这些计划可实现适度的体重减轻、降低血糖并降低未来患 T2D 的风险。在一项这样的试验中，DPP 非常有效——它使糖尿病的发病率降低了 58%。然而，其在社区环境中的有效性和可持续性需要进一步研究。我们提出的研究旨在填补这一空白。我们将在 AA 教会会众中实施健身身体和灵魂干预。这一战略与社区组织（尤其是教会）参与健康促进的日益增长的趋势是一致的。我们建议对超重的 AA 教会参与者进行整群随机社区试验 (BMIe25)。这是建立在我们之前对 AA 社区的研究、我们最近确定的 20 家渴望参与 AA 教会的研究以及我们的试点研究结果的基础上的。目标 1：评估为期 3 个月的 Fit Body and Soul 干预措施对 T2D 高风险人群的有效性。目标 2：确定 Fit Body and Soul 干预是否比控制臂更具成本效益。控制措施将采用目前可接受的、科学合理的健康教育计划，这些计划源自 CDC 社区指南。干预和控制计划都将由专家领导的教会健康顾问实施，并得到教会牧师的支持。主要结果是体重减轻（至少基线体重的 7%）。次要结果是增加 PA（每周至少 150 分钟中等强度运动）、改善饮食选择以及降低血糖 (e3mg/dL)。数据收集将在基线以及干预后 6 个月和 12 个月进行。如果发现“健康的身体和灵魂”干预措施有效，那么未来将进行一项有效性研究，以确定这种干预措施是否可以降低 T2D 的发病率以及相关的死亡率和发病率。项目叙述 事实证明，在医疗保健环境中，促进采用健康的生活方式（包括饮食和锻炼的最佳实践以及大量专家支持）可以降低高危人群患 2 型糖尿病的发病率。在拟议的研究中，我们希望表明相同或类似的计划在医疗保健领域之外的社区环境（我们研究中的非裔美国人社区）中是有效的。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，我们将确定通过行为生活方式计划（健身身体和灵魂）是否不仅可以减少危险因素，还可以减少糖尿病本身（及其相关的死亡率和发病率），已针对基于信仰的社会文化环境进行了修改。