Translating Research into Prevention of Diabetes (TRIP Diabetes)

描述（由申请人提供）：虽然诸如糖尿病预防项目这样的试验已经证明了通过生活方式干预预防2型糖尿病（DM）的巨大潜力，但一个关键的知识缺口是这种方法是否可以在社区中实施。我们的目标是通过试点测试的关键翻译将糖尿病预防研究转化为社区实践，以提高后勤和财政可行性和传播，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）在标准化信息视频和其他工具的帮助下，3)通过创新地扩展现有的糖尿病教育项目，在社区环境中提供干预措施，并与作为授权社区合作伙伴的lhc合作。我们提出了一项480名参与者的随机试验，以验证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且具有临床意义的影响：空腹血糖（主要结局）、身体活动、饮食摄入、体重和腰围（次要结局）以及其他第三结局。将进行经济评估以确定成本效益。一个试验组将包括以群体为基础的强化生活方式干预，促进健康饮食，增加身体活动，并在早期6个月的强化阶段实现适度但可实现的（5-7%）体重减轻，随后是18个月的维持阶段。lhc将用于强化干预治疗。对照部分将包括个人教育干预，结合现有的社区资源，帮助居民选择更健康的生活方式。根据审稿人的意见和我们试点工作的结果，我们修改了我们的计划。我们更详细地描述了我们的组织计划，并增加了我们用于培训、监测和支持lhc发挥作用的资源分配。我们制定了包括视频在内的干预工具草案，以加强干预措施提供和随后传播的标准化。我们已经试点了我们提出的LHC招募和培训方法，以及参与者招募、评估和早期干预方法。我们改进了分析计划的描述。我们有信心能够完成这个重要的翻译项目。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美国社区的糖尿病教育项目。

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.