Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

描述（由申请人提供）：两项具有里程碑意义的临床试验，展望（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导致适度的体重减轻和增加体力活动可以改善对心脏代谢危险因素的控制，并且可能是对血糖异常患者（即糖尿病或糖尿病前期）资源的经济有效利用。尽管这些疾病共同影响了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实施而设计的。初级保健机构非常适合识别、激活和提供血糖异常成人的随访，但这些机构远不如许多社区组织为大量不断增长的人口提供强化行为干预。我们与初级保健诊所和基督教青年会的领导合作了6年多，设计并预先测试了一个实用的模型，用于识别、咨询和转诊高风险初级保健患者，以便在基督教青年会的设施中采用基于群体的适应DPP生活方式干预。两笔R34计划拨款的初步数据有力地支持了YMCA可以实施基于群体的DPP生活方式干预，并实现与原始DPP模型相当的体重减轻（-6.0%;95% CI -4.6至-7.4%）。与这些发现相平行的是，Look AHEAD的新结果表明，在提供非常相似的强化生活方式干预的成人2型糖尿病患者中，类似的体重减轻和心脏代谢危险因素的有意义的改善是可以实现的，也是安全的。因此，我们提出了这项新的研究，以评估在初级保健机构中识别患有血糖不良（糖尿病或糖尿病前期）的成人的合作方法的成本和有效性，并在社区ymca中提供基于群体的强化生活方式干预，该方法已经过DPP和Look AHEAD方法的精心改编。这种干预将包括初级保健和社区计划之间更有组织的联系，以帮助临床医生改善这些患者的心脏代谢风险管理。该研究将涉及8个初级保健诊所和6个YMCA站点，并将采用定性和定量方法的混合，在2年的干预期内，评估干预活动的范围，采用，实施和维持，并建立一个实际的随机有效性试验，以评估这种合作干预的效果，以实现和维持适度的体重减轻，并改善患有血糖异常的成人初级保健患者的心脏代谢风险。如果我们的研究发现这种合作干预策略是有效和可持续的，那么结果将是及时有效地传播这种方法作为解决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.