REAL HEALTH-Diabetes: REach Ahead for Lifestyle and Health-Diabetes

描述（由申请人提供）：肥胖和糖尿病这对孪生流行病影响着大多数美国人：70%的美国成年人超重或肥胖，2600万人患有糖尿病，7900万人患有糖尿病前期。虽然饮食和运动可以改善糖尿病的预后，但大多数2型糖尿病患者饮食不健康，很少进行体力活动，并且难以改变和维持健康行为。展望未来的试验表明，一个强化的生活方式干预，教必要的技能，使饮食和活动的变化， 与糖尿病支持和教育相比，糖尿病支持和教育导致持续体重减轻、糖尿病缓解、并发症发生率降低、药物减少以及身体健康和生活质量改善。该项目将调整高效但资源密集型的Look AHEAD强化生活方式干预，以便在社区卫生中心环境中以更少的资源提供，可能通过电话提供，大大扩大其潜在范围和影响。试点数据显示，可行性和有效性与展望未来的生活方式干预：生活方式组的参与者体重减轻了6.7%，而个体医学营养治疗（MNT）组的体重减轻了2.6%（P=0.003），并且药物减少了两倍。在这个项目中，我们将比较两种不同的实施策略，以提供这一组适应展望未来的强化生活方式干预，一个使用面对面的方法，一个使用电话的方法，营养师转诊为超重的2型糖尿病患者的个体医学营养治疗。发言将在 三个社区卫生服务中心。将在基线、6、12、24和36个月时测量结局。目标1：在一项三组试验中评价调整后的Look AHEAD生活方式改变干预措施的比较有效性，该试验将随机分配至面对面（IP）组（n=70）和电话会议（TCC）组（n=70），实施策略与定义为个体MNT（对照; n=70）的标准治疗进行比较。医疗结局将包括体重减轻（主要）、血糖控制、心脏风险因素、药物剂量和费用。行为结果包括自我效能和健康相关的生活质量。目标二：评估适应展望未来生活方式改变计划在三个社区卫生中心设置的面对面和电话实施策略中的覆盖范围、采用、实施保真度和维护，使用RE-AIM模型维度项目检查表比较各中心的因素，并采用混合方法，包括焦点小组和结构化访谈。目标3：估计与常规护理相比，本研究中评估的实施策略的体重每降低一个百分点的增量成本。如果有效的话，该项目的大致实施成本估计材料可以很容易地在美国各地的普通护理环境中传播使用。

DESCRIPTION (provided by applicant): The twin epidemics of obesity and diabetes affect most Americans: 70% of US adults are overweight or obese, 26 million have diabetes, and 79 million people have pre-diabetes. While diet and exercise improve outcomes in diabetes, most people with type 2 diabetes eat an unhealthy diet, do little physical activity, and have trouble making and sustaining changes in health behavior. The Look AHEAD trial demonstrated that an intensive lifestyle intervention that teaches skills necessary to make changes in diet and activity led to sustained weight loss, diabetes remission, lower rates of complications, medication reduction, and improved physical fitness and quality of life compared to diabetes support and education. This project will adapt the highly effective but resource-intensive Look AHEAD intensive lifestyle intervention so that it may be delivered with fewer resources in community health center settings, potentially via telephone, greatly expanding its potential reach and impact. Pilot data show feasibility and effectiveness comparable to the Look AHEAD lifestyle intervention: lifestyle group participants lost 6.7% of body weight compared to 2.6% in the individual medical nutrition therapy (MNT) arm (P=0.003) and had twice as much reduction in medications. In this project, we will compare two different implementation strategies for delivery of this group adaptation of the Look AHEAD intensive lifestyle intervention, one using an in-person approach and one using a telephone approach, to dietitian referral for individual medical nutrition therapy in overweight patients with type 2 diabetes. The interventions will take place at three community health centers. Outcomes will be measured at baseline, 6, 12, 24, and 36 months. Aim 1: To evaluate the comparative effectiveness of the adapted Look AHEAD lifestyle change interventions in a three-arm trial comparing random assignment to in-person (IP) group (n=70) and telephone conference call (TCC) group (n=70) implementation strategies to standard of care defined as individual MNT (control; n=70). Medical outcomes will include weight loss (primary), glycemic control, cardiac risk factors, medication dose, and cost. Behavioral outcomes include self-efficacy and health-related quality of life. Aim 2: To evaluate the reach, adoption, implementation fidelity, and maintenance of the adapted Look AHEAD lifestyle change program in in-person and telephone call implementation strategies at the three community health center settings, comparing factors across centers using the RE-AIM Model Dimension items checklist and employing a mixed methods approach including focus groups and structured interviews. Aim 3: To estimate the incremental cost per percentage point decrease in body weight of the implementation strategies assessed in this study compared to usual care. If effective, materials with estimates of approximate implementation costs from this project can be readily disseminated for use in usual care settings throughout the United States.