Translating Research into Prevention of Diabetes (TRIP Diabetes)

将研究转化为糖尿病预防（TRIP 糖尿病）

• 批准号: 7149753
• 负责人: DAVID C GOFF
• 金额: $ 73.88万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7149753
• 关键词: behavior therapy; behavioral /social science research tag; body composition; clinical research; clinical trials; community health services; cost effectiveness; disease /disorder prevention /control; early /brief intervention /therapy; glucose tolerance; health care personnel education; health service demonstration project; human subject; human therapy evaluation; information dissemination; longitudinal human study; medical outreach /case finding; noninsulin dependent diabetes mellitus; obesity; patient oriented research; physical fitness; questionnaires; videotape /videodisc; weight control

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.

描述（由申请人提供）：虽然糖尿病预防计划等试验已证明通过生活方式干预预防 2 型糖尿病 (DM) 具有巨大潜力，但关键的知识差距是这些方法是否可以在社区实施。我们的目标是通过关键转化将糖尿病预防研究转化为社区实践，这些转化已经过试点测试，以增强后勤和财政可行性和传播，包括 1) 根据肥胖和空腹血糖寻找糖尿病前期病例，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)，并借助标准化信息视频和其他工具，以及 3) 通过与 LHC 合作创新扩展现有糖尿病教育计划，在社区环境中提供干预措施作为赋权的社区合作伙伴。我们提出了一项 480 名参与者的随机试验，以检验以下假设：通过基于社区的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（主要结果）、体力活动、饮食摄入、体重、和腰围（次要结果），以及其他三级结果。将进行经济评估以确定成本效益。其中一个试验组将包括基于小组的强化生活方式干预，促进健康饮食、增加体力活动以及在早期 6 个月的强化阶段中实现适度但可实现的 (5-7%) 减肥，随后是 18 个月的维持阶段。大型强子对撞机将用于强化干预组。控制臂将包括个人教育干预，其中结合了现有的社区资源，可帮助居民做出更健康的生活方式选择。我们根据评审员的意见和试点工作的结果修改了我们的计划。我们更详细地描述了我们的组织计划，并增加了对大型强子对撞机的培训、监测和支持的资源分配。我们开发了包括视频在内的干预工具草案，这将加强干预实施和后续传播的标准化。我们已经试点了我们提出的大型强子对撞机招募和培训以及参与者招募、评估和早期干预的方法。我们改进了分析计划的描述。我们有信心能够开展这一重要的转化项目。如果强化干预方法具有成本效益，则该模型可以通过糖尿病教育计划传播到数千个美国社区。 许多慢性疾病受到活动和饮食的影响。我们的生活方式干预如果成功，应该会转化为 2 型糖尿病以外领域的公共健康益处，例如肥胖、高血压、心血管健康和癌症预防，从而大大增加社会的潜在益处。