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

描述(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)通过适度的减肥和体力活动为初级预防提供了强大的疗效基础。然而，到目前为止，针对高危青年的研究成果非常有限。我们的首要目标是开发、提供和严格评估一种新的三组分干预措施，以降低人工智能青年T2D的风险。这项干预措施旨在广泛、可持续地传播和实施，采用核心内容的结构、可互换的特定部落模块和详细手册，以促进高保真的实施。我们这项应用的目标是a)进一步开发名为部落转折点计划(TTPP)的翻译干预措施，以及b)生成数据为R18应用程序提供信息。TTPP通过以下方式针对饮食和体力活动：1)针对儿童/父母二元组的动机访谈(MI)，以促进问题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、文化上合适的主动学习修改；以及3)基于社会生态模型，提供文化上合适的转折点工具箱，以支持MI和主动学习组成部分。我们在切诺基人和纳瓦霍人之间建立了合作伙伴关系，得到了北卡罗来纳大学、科罗拉多大学丹佛分校(UCD)、总部设在UCD的美国印第安人和阿拉斯加土著糖尿病转化研究中心(CAIANDTR)以及多元化咨询委员会的支持。我们共同提出了以下目标：目标1(第1年)：通过基于社区的参与性研究过程进一步发展TTPP，以确保1)与基于DPP的基金会的忠诚度；2)与儿科体重管理文献中的证据一致；以及3)其他人工智能社区采用可持续计划交付的能力。目标2(第1年和第2年)：通过与印度卫生服务(IHS)赞助的印度人特殊糖尿病计划(SDPI)示范项目的合作，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(2年级)：在两个地点(切诺基和纳瓦霍，总计n=60名8-10岁的青年)中，30名超重或肥胖的AI青年与父母或其他主要照顾者分别在两个地点(Cherokee和Navajo，总数n=60，年龄8-10岁)中进行TTPP的试点和可行性试验，随机分为干预组和对照组。主要结果是体重指数和空腹胰岛素浓度。结果将通知在R34试验和可行性研究完成后不久将在R18应用中提议的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，将是SDPI计划在成人中取得成功的关键扩展，以满足在人工智能青年中降低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.