Translating Research into Prevention of Diabetes (TRIP Diabetes)

描述(由申请人提供)：虽然糖尿病预防计划等试验已经证明，通过生活方式干预预防2型糖尿病(DM)具有巨大的潜力，但关键的知识缺口是这种方法是否可以在社区实施。我们的目标是通过关键的翻译将糖尿病预防研究转化为社区实践，这些翻译已经过试点测试，以增强后勤和财务的可行性和传播，包括1)发现基于肥胖和空腹血糖的糖尿病前期病例，2)使用基于群体的生活方式干预，聘请专业和非专业健康顾问(LHC)，并辅之以标准化的信息视频和其他工具，以及3)通过创新扩展现有的糖尿病教育计划，与LHC合作，作为授权的社区合作伙伴，在社区环境中提供干预。我们提出了一项有480名参与者参加的随机试验，以检验这样一种假设，即通过社区糖尿病预防计划实施的生活方式干预将对以下方面产生有益和临床有意义的影响：空腹血糖(主要结果)、体力活动、饮食摄入量、体重和腰围(次要结果)和其他第三结果。将进行经济评估，以确定成本效益。其中一项试验将包括以小组为基础的强化生活方式干预，促进健康饮食，增加体力活动，在早期6个月的强化阶段实现适度(5%-7%)的减肥，然后进行18个月的维持阶段。强化干预组将使用低碳氢化合物。控制部门将包括个人教育干预，结合现有的社区资源，帮助居民做出更健康的生活方式选择。我们已经根据审查员的意见和试点工作的结果修改了我们的计划。我们已更详细地介绍了我们的组织计划，并增加了资源分配，用于培训、监测和支持LHC发挥其作用。我们制定了干预工具草案，包括视频，这将加强干预提供和随后传播的标准化。我们已经试行了我们建议的大型强子对撞机招募和培训方法，以及参与者招募、评估和早期干预的方法。我们改进了对分析计划的描述。我们有信心能够开展这一重要的翻译项目。如果强化干预方法具有成本效益，这种模式可以传播到数千个有糖尿病教育计划的美国社区。 许多慢性病都受运动和饮食的影响。如果我们的生活方式干预成功，应该会转化为2型糖尿病以外的领域的公共健康益处，如肥胖症、高血压、心血管健康和癌症预防，从而极大地增加社会的潜在好处。

DESCRIPTION (provided by applicant): While trials such as the Diabetes Prevention Program have demonstrated a significant potential for the prevention of type 2 diabetes mellitus (DM) through lifestyle interventions, a critical knowledge gap is whether such approaches can be implemented in the community. Our goal is to translate DM prevention research into community practice via key translations that have been pilot-tested to enhance logistical and fiscal feasibility and dissemination including 1) finding prediabetes cases based on adiposity and fasting glucose, 2) the use of a group-based lifestyle intervention employing professional and lay health counselors (LHCs) aided by standardized informational videos and other tools, and 3) delivery of the intervention in the community setting via innovative expansion of an existing diabetes education program collaborating with LHCs as empowered community partners. We propose a 480-participant randomized trial to test the hypothesis that a lifestyle intervention administered through a community-based diabetes prevention program will have a beneficial and clinically meaningful impact on: fasting glucose (primary outcome), physical activity, dietary intake, weight, and waist circumference (secondary outcomes), and other tertiary outcomes. An economic evaluation will be conducted to determine cost effectiveness. One trial arm will consist of a group-based intensive lifestyle intervention promoting healthy eating, increased physical activity and modest, yet achievable (5-7%) weight loss delivered in an early 6-month intensive phase followed by an 18-month maintenance phase. LHCs will be utilized in the intensive intervention arm. The control arm will consist of an individual educational intervention that incorporates existing community resources that are available to assist residents in making healthier lifestyle choices. We have revised our plan based on the reviewers' comments and the results of our pilot work. We have described our organizational plan in greater detail and increased our resource allocation for training, monitoring and supporting the LHCs in their roles. We have developed drafts of intervention tools, including videos, that will enhance standardization of intervention delivery and subsequent dissemination. We have piloted our proposed methods of LHC recruitment and training, and participant recruitment, assessment and early intervention. We have improved the description of our analytic plan. We are confident we can conduct this important translational project. If the intensive intervention approach is cost-effective, this model could be disseminated to the thousands of U.S. communities with diabetes education programs. Many chronic diseases are influenced by activity and diet. Our lifestyle intervention, if successful, should translate into public health benefits in areas other than type 2 DM, such as obesity, hypertension, cardiovascular health and cancer prevention, thus greatly multiplying the potential benefits for society.