A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics

描述（由申请人提供）：超重在美国是一种流行病。患有糖尿病前期的肥胖或超重个体处于进展为糖尿病的高风险中。体重减轻是这些个体糖尿病发病率降低的主要预测因素。至少在研究环境中，通过频繁、面对面、个体化的方式进行强化生活方式干预，可有效实现并维持糖尿病前期人群的临床显著（≥ 5%）体重减轻。替代的、更有效的提供方式，特别是团体治疗和基于互联网的生活方式干预，已经证明是有效的。然而，他们的有效性，成本效益，普遍性和可持续性在常规初级保健设置尚未调查。 此申请响应了“糖尿病和肥胖症预防和控制转化研究计划赠款”的号召。“我们建议在初级保健环境中对肥胖或超重以及空腹血糖受损的患者进行定制持续护理管理（CCCM）模型的试点测试。CCCM肥胖干预基于减肥和维持策略，这些策略已经被证明在多种族人群中有效。为期6个月的干预将包括两个不同的阶段：一个为期2个月的强化阶段，包括一个小组定向和一个为期6周的减肥课程，以及一个随后的维持阶段，该阶段将依靠在线疾病管理系统进行持续的自我监测和电子咨询。该在线系统与领先的商用电子健康记录（EHR）系统完全集成，该系统包括个人健康记录和安全的患者-临床医生消息传递功能。我们的具体目标是： 1.在Palo Alto医学基金会的Los阿尔托斯中心进行一项2组试点试验，该基金会是一个大型的、基于社区的、多专业的团体实践。我们将130例年龄≥ 18岁、体重指数（BMI）≥ 25 kg/m2、空腹血糖受损100-125 mg/dL的非糖尿病、非妊娠患者随机分配至CCCM或常规治疗组。 2.评估CCCM在改善患者结局方面的有效性，包括BMI（主要结局）、腰围、临床和生活方式风险因素以及生活质量。我们的主要假设是，CCCM患者在6个月内的BMI下降幅度将大于常规治疗的患者。我们将研究干预效果的调节者和中介者。我们将使用对干预的反应估计值及其变化，为后续的全面随机临床试验（RCT）提供信息。 3.使用过程措施（例如，招募和保留的可行性，干预措施的吸收和坚持，参与者和提供者的满意度）。这些信息将指导我们在随后的RCT中评估CCCM的覆盖范围、采用、实施和维护。 如果在当前和随后的评估中证明是成功的，CCCM将过渡到PAMF范围内的计划，并有可能广泛传播到现有EHR的卫生系统。 公共卫生相关性：在初级保健环境中，具有其他风险因素（如空腹血糖受损）的肥胖或超重患者的体重减轻是高度优先的;然而，这些环境中的肥胖管理迄今为止在很大程度上是失败的。在这项申请中，我们提出了试点测试定制的持续护理管理（CCCM）计划，其中基于证据的减肥和维持策略将在小组会议中提供初始，强化减肥治疗，并通过在线疾病管理系统进行持续维护。如果在当前和随后的评估中证明是成功的，我们的CCCM计划有可能为在一系列初级保健环境中建立针对肥胖和其他慢性病的定制，持续护理管理提供蓝图。

DESCRIPTION (provided by applicant): Excess body weight is an epidemic in the United States. Obese or overweight individuals with pre-diabetes are at high risk of progression to diabetes. Weight loss is the dominant predictor of reduced diabetes incidence in these individuals. Intensive lifestyle interventions delivered in frequent, face-to-face, individual sessions are effective, at least when delivered in a research setting, in achieving and maintaining clinically significant (=5%) weight loss in pre-diabetic populations. Alternative, more efficient delivery modalities, particularly group therapy and Internet-based lifestyle intervention, have demonstrated efficacy. However, their effectiveness, cost- effectiveness, generalizability, and sustainability in routine primary care settings have not been investigated. This application responds to the call for "Planning Grants for Translational Research for the Prevention and Control of Diabetes and Obesity." We propose pilot testing a Customized Continuous Care Management (CCCM) model with patients who are obese or overweight and have impaired fasting glucose in a primary care setting. The CCCM obesity intervention is based on weight loss and maintenance strategies already proven effective for use in multi-ethnic populations. The 6-month intervention will include 2 distinct stages: a 2-month intensive stage that will involve a group orientation and a 6-week weight loss class and a subsequent maintenance stage that will rely on an Online Disease Management system for ongoing self-monitoring and e-counseling. The online system is fully integrated with a leading, commercially available electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. Our specific aims are to: 1. Conduct a 2-arm pilot trial at the Los Altos Center of the Palo Alto Medical Foundation, a large, community- based, multi-specialty group practice. We will randomize 130 non-diabetic, non-pregnant patients =18 yrs who have a body mass index (BMI) =25 kg/m2 and impaired fasting glucose of 100-125 mg/dL to CCCM or usual care. 2. Evaluate the effectiveness of CCCM in improving patient outcomes, including BMI (primary outcome), waist circumference, clinical and lifestyle risk factors, and quality of life. Our primary hypothesis is that CCCM patients will experience greater reductions in BMI over 6 months than those in usual care. We will examine moderators and mediators of the intervention effects. We will use the estimates of response to the intervention and variation therein to inform a subsequent, full-scale randomized clinical trial (RCT). 3. Evaluate the implementation feasibility and potential sustainability of CCCM using process measures (e.g., feasibility of recruitment and retention, intervention uptake and adherence, participant and provider satisfaction). This information will guide our efforts to evaluate the reach, adoption, implementation, and maintenance of CCCM in the subsequent RCT. If proven successful in the current and subsequent evaluations, the CCCM will be transitioned to a PAMF- wide program and also will have the potential to be widely disseminated to health systems with existing EHRs. PUBLIC HEALTH RELEVANCE: Weight loss in obese or overweight patients with additional risk factors, such as impaired fasting glucose, is of high priority in primary care settings; however, obesity management in these settings has thus far been largely a failure. In this application, we propose pilot-testing a Customized Continuous Care Management (CCCM) program in which evidence-based weight loss and maintenance strategies will be delivered in group sessions for initial, intensive weight loss therapy and via an Online Disease Management system for ongoing maintenance. If proven successful in the current and subsequent evaluations, our CCCM program has the potential to provide a blueprint for instituting customized, continuous care management for obesity and other chronic conditions in a range of primary care settings.