Tribal Turning Point: Pilot Study for Prevention of T2D in American Indian Youth

描述（由申请人提供）：2型糖尿病（T2D）在青少年中出现，特别是美国印第安人（AI）青年。糖尿病预防计划（DPP）为通过适度减肥和体育活动进行一级预防提供了强有力的疗效基础。然而，迄今为止对高危青少年的研究取得的成功非常有限。我们的首要目标是开发、提供并严格评估一种新的三组分干预措施，以降低AI青少年患T2D的风险。该干预措施旨在广泛、可持续地传播和实施，使用具有可交换、特定部落模块和详细手册的核心内容结构，以促进高保真地实施。我们这一应用程序的目标是：a)进一步开发一个名为“部落转折点计划”（TTPP）的翻译干预；b)生成数据，为R18应用程序提供信息。TTPP通过：1)对儿童/父母进行动机性访谈（MI），以促进问题的解决和行为目标的实现；2)在小组环境中，为人工智能父母和青少年提供翻译的、文化上适当的主动学习修改的DPP；3)在社会生态模型的基础上，建立一个文化上合适的转折点工具箱，以支持MI和主动学习组件。我们在北卡罗来纳大学、科罗拉多大学丹佛分校（UCD）、位于UCD的美国印第安人和阿拉斯加原住民糖尿病转化研究中心（CAIANDTR）以及一个多元化的咨询委员会的支持下，在切罗基人和纳瓦霍人之间建立了伙伴关系。我们共同提出以下目标：目标1（第一年）：通过以社区为基础的参与性研究过程进一步发展tpp，以确保1)忠实于以dpp为基础的基础；2)与儿童体重管理文献证据的一致性；3)其他人工智能社区采用可持续项目交付的能力。目标2（1年级和2年级）：通过与印度卫生服务（IHS）赞助的印度人特殊糖尿病计划（SDPI）示范项目合作，确保最终在多个人工智能社区广泛传播和可持续实施。目标3（二年级）：开展为期8个月的TTPP试点和可行性试验，在两个地点（切罗基和纳瓦霍，共60名8-10岁青少年）的30名超重或肥胖的AI青少年中进行（父母或其他主要照顾者）。主要结局是BMI和空腹胰岛素浓度。结果将在R34试验和可行性研究完成后不久，在R18申请中提出一项全功率随机临床试验。通过这一转化研究过程推进部落转折点计划，将为成人SDPI计划的成功提供重要的扩展，以解决降低AI青年T2D风险的迫切需求。

DESCRIPTION (provided by applicant): Type 2 diabetes (T2D) has emerged among adolescents, particularly American Indian (AI) youth. The Diabetes Prevention Program (DPP) provides a strong efficacy base for primary prevention through moderate weight loss and physical activity. However studies to date among high risk youth have had very limited success. Our overarching goal is to develop, deliver and rigorously evaluate a novel three-component intervention to reduce risk for T2D in AI youth. The intervention is designed for broad, sustainable dissemination and implementation, using a structure of core content with exchangeable, tribe-specific modules and detailed manuals to facilitate high fidelity implementation. Our objectives for this application are a) to further develop a translational intervention called the Tribal Turning Point Program (TTPP) and b) to generate data to inform an R18 application. The TTPP targets diet and physical activity through: 1) motivational interviewing (MI) for child/parent dyads to facilitate problem solving and behavioral goal attainment; 2) a translational, culturally appropriate active-learning modification of the DPP for AI parents and youth delivered in a group setting; and 3) a culturally appropriate Turning Point Toolbox to support the MI and active learning components, based on the social ecologic model. We have established a partnership between Cherokee and Navajo, supported by the University of North Carolina, the University of Colorado Denver (UCD), the UCD-based Center for American Indian and Alaska Native Diabetes Translational Research (CAIANDTR), and a diverse Advisory Board. Together we propose the following Aims: Aim 1 (Year 1): To further develop the TTPP through a community-based participatory research process to ensure 1) fidelity with the DPP-based foundation; 2) consistency with evidence from the pediatric weight management literature; and 3) capacity for adoption by other AI communities for sustainable program delivery. Aim 2 (Years 1 and 2): To ensure eventual wide dissemination and sustainable implementation across multiple AI communities through a partnership with Indian Health Service (IHS)-sponsored Special Diabetes Program for Indians (SDPI) demonstration projects. Aim 3 (Year 2): To conduct an 8-month pilot and feasibility trial of the TTPP, among 30 overweight or obese AI youth with a parent or other primary caregiver in each of two sites (Cherokee and Navajo, total n=60 youth age 8-10yr), randomized to intervention or control. Primary outcomes are BMI and fasting insulin concentration. Results will inform a fully powered randomized clinical trial to be proposed in an R18 application shortly following completion of the R34 pilot and feasibility study. Advancement of the Tribal Turning Point Program through this translational research process will provide a critical extension of the successes of the SDPI programs in adults to address the compelling need to reduce risk of T2D among AI youth.