Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

描述(申请人提供)：两项里程碑式的临床试验，Look Award(糖尿病健康行动)和糖尿病预防计划(DPP)已经证明，密集的生活方式干预可以适度减肥和增加体力活动，可以改善心脏代谢风险因素的控制，并且很可能是对患有血糖障碍(即糖尿病或糖尿病前期)的人成本效益高的资源使用。尽管这些疾病加在一起影响了8000多万美国人，但展望未来和DPP生活方式干预措施并不是为在人口规模上提供而设计的。初级保健机构非常适合识别、激活和为患有血糖障碍的成年人提供随访，但这些机构的装备远远低于许多社区组织，无法向数量庞大且不断增长的人口提供强化的行为干预。我们与初级保健诊所和基督教青年会的领导层合作了6年多，设计并预先测试了一个实用模式，以识别、咨询和转介高危初级保健患者，以便在青年会设施中获得基于群体的DPP生活方式干预。来自两个R34规划赠款的初步数据提供了强有力的支持，表明基督教青年会可以实施基于群体的DPP生活方式干预，并实现与原始DPP模型相当的减肥效果(-6.0%；95%CI-4.6%至-7.4%)。在这些发现的同时，展望未来的新结果表明，在接受非常类似的强化生活方式干预的2型糖尿病成年人中，类似的体重减轻和心脏代谢风险因素的有意义的改善是可以实现的和安全的。因此，我们建议进行这项新的研究，以评估协作方法的成本和有效性，该方法用于在初级保健环境中识别患有血糖异常的成年人(无论是糖尿病还是糖尿病前期)，并提供在社区基督教青年会进行基于群体的强化生活方式干预的机会，该干预已从DPP和前瞻性方法中仔细改编。这一干预措施将包括初级保健和社区计划之间的更多结构化联系，以帮助临床医生改善对这些患者心脏代谢风险的管理。这项研究将涉及8家初级保健诊所和6个基督教青年会地点，并将采用定性和定量相结合的方法，在为期两年的干预期内，评估干预活动的覆盖范围、采用、实施和维持，并开展一项实用的随机有效性试验，以评估这种配对干预措施的效果，以实现和保持适度的体重减轻，并改善患有血糖异常的成年初级保健患者的心脏代谢风险。如果我们的研究发现这种伙伴干预策略是有效和可持续的，其结果将是及时和有效地传播这一方法作为应对糖尿病流行的全国模式的关键。

DESCRIPTION (provided by applicant): Two landmark clinical trials, Look AHEAD (Action for Health in Diabetes) and the Diabetes Prevention Program (DPP) have demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can improve control of cardiometabolic risk factors and is likely to be a cost-effective use of resources for persons with dysglycemia (i.e. either diabetes or pre-diabetes). Although these conditions together affect over 80 million Americans, the Look AHEAD and DPP lifestyle interventions were not designed for delivery on a population scale. Primary care settings are well suited to identify, activate, and provide follow-up for adults with dysglycemia, but these settings are far less equipped than many community organizations to offer intensive behavioral interventions to a large and growing population. We have collaborated with the leadership of primary care clinics and the YMCA for over 6 years to design and pre-test a practical model to identify, counsel, and refer high-risk primary care patients for access to a group-based adaptation of the DPP lifestyle intervention in YMCA facilities. Preliminary data from two R34 planning grants provides strong support that the YMCA can implement a group-based DPP lifestyle intervention and achieve weight loss that is comparable to the original DPP model (-6.0%; 95% CI -4.6 to -7.4%). In parallel to these findings, emerging results from Look AHEAD have demonstrated that similar weight reduction and meaningful improvements in cardiometabolic risk factors are achievable and safe in adults with type 2 diabetes who are offered a very similar intensive lifestyle intervention. As a result, we propose this new study to evaluate the costs and effectiveness of a collaborative approach to identify adults with dysglycemia (either diabetes OR pre-diabetes) in primary care settings and to provide access to a group-based intensive lifestyle intervention at community-based YMCAs that has been carefully adapted from both the DPP and Look AHEAD approaches. This intervention will include more structured linkages between primary care and the community program to help clinicians improve the management of cardiometabolic risk in these patients. The study will involve 8 primary care clinics and 6 YMCA sites and will employ a mix of qualitative and quantitative methods, over a 2-year intervention period, to evaluate the reach, adoption, implementation, and maintenance of intervention activities, and to mount a practical randomized effectiveness trial to evaluate the effect of this partnered intervention to achieve and maintain modest weight loss and improved cardiometabolic risk in adult primary care patients with dysglycemia. Should our study find this partnered intervention strategy to be effective and sustainable, the results will be pivotal to the timely and efficient dissemination of this approach as a nationwide model to address the diabetes epidemic.