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（T2 D）。我们提出的研究的直接目标是通过促进健康生活方式的采用来减少糖尿病风险因素。在这项R-18提案中，我们计划通过基于信仰的活动和设置来评估生活方式干预的“有效性”和“成本效益”，即非洲裔美国人的健康身体和灵魂。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为基础的“糖尿病预防计划”（DPP）的生活方式组成部分，已修改与小组参与。适合的身体和灵魂计划将提供AA教会与他们的牧师和教会官员的伙伴关系，随着沿着的指导，从民进党和身体和灵魂计划的专家。我们将看看拟议的干预措施是否能有效减少超重、缺乏身体活动和血糖升高（T2 D的风险因素）。我们将重点关注AA，这是一个具有更多T2 D和更多T2 D风险因素的群体，包括更多的糖尿病前期，肥胖和身体活动不足。幸运的是，最近的临床试验表明，强化的生活方式改变计划可以成为T2 D高风险成年人的“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），这些计划导致适度的体重减轻，降低血糖并降低未来T2 D的风险。其中一项试验，DPP是有效的-它导致糖尿病减少了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。我们的研究旨在填补这一空白。我们将在AA教会会众中实施适合身体和灵魂的干预。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。我们提出了一个集群随机社区试验的AA教会参与者谁是超重（BMIe 25）。这建立在我们以前在AA社区的研究，我们最近确定的20个AA教会渴望参与，以及我们的试点研究结果。目的1：评估为期3个月的身心健康干预对T2 D高危人群的有效性。目标二：为了确定健身和灵魂干预是否比对照组更具成本效益，对照组将接受目前可接受的和科学合理的健康教育计划，来自CDC社区指南。干预和控制计划将由专家领导的教会健康顾问提供，并得到教会牧师的支持。主要结局是体重减轻（至少为基线体重的7%）。次要结果是增加PA（每周至少150分钟的中等强度运动），改善饮食选择，降低血糖（e3 mg/dL）。数据收集将在基线和干预后6个月和12个月进行。如果发现“身心健康”干预措施有效，将开展未来的有效性研究，以确定这种干预措施是否能降低T2 D的发病率以及相关的死亡率和发病率。研究表明，促进健康生活方式的采用，包括饮食和运动的最佳实践以及大量的专家支持，可以在医疗保健环境中降低高危人群中2型糖尿病的发病率。在拟议的研究中，我们希望表明，相同或类似的计划是有效的，在社区设置（非洲裔美国人社区在我们的研究），医疗保健竞技场以外。如果成功，我们的研究将为未来的有效性研究提供科学依据，在该研究中，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（适合身体和灵魂）来减少，该计划已针对社会文化信仰进行了修改。