Tailored Lifestyle Intervention in Obese Adults within Primary Care Practice

描述（由申请人提供）：我们提出了一项随机对照群设计的临床试验，以评估一种创新的、量身定制的生活方式干预在初级保健实践中对超重和肥胖患者的有效性。该研究将分为两个阶段：第一阶段-干预改进，第二阶段-随机设计集群临床试验，包括20名初级保健提供者和200名患者。在干预改进阶段，患者焦点小组将为方案的改进提供信息，并帮助调整我们的干预材料，以适应行为减肥、身体活动和饮食改变。这项随机临床试验（RCT）将比较增强常规护理和以家庭为基础的超重/肥胖患者的生活方式咨询，采用个性化的干预措施，以饮食和身体活动行为改变为重点，通过印刷品提供，并辅以支持性电话咨询和视频。每个PCP实践将通过学术细节接受肥胖教育，并通过手持设备实施肥胖管理指南，而干预PCP实践将收到每位患者行为目标实现的季度进度报告。通过意向治疗分析，RCT的主要结果将是两年内BMI、身体活动和饮食变化的变化。该RCT需要评估的其他结果包括：干预成本和通过比较每单位BMI损失的干预成本以及身体活动和饮食改变的成本-效果评估。通过证明一种实用的生活方式干预的有效性，对从初级保健实践中招募的患者进行有限的面对面接触，在体重指数、身体活动和健康饮食习惯方面产生临床有意义的变化，拟议试验的结果将与临床实践直接相关。这项研究将填补我们在从疗效研究到社区环境最佳实践的研究的翻译和传播方面的知识的重要空白——这是NIH路线图倡议的一个重要目标。

DESCRIPTION (provided by applicant): We propose a randomized controlled cluster designed clinical trial to evaluate the effectiveness of an innovative, tailored lifestyle intervention on overweight and obese patients in primary care practice. The study will have two phases: Phase 1 - Intervention refinement, Phase 2- Randomized design cluster clinical trial with 20 primary care providers and 200 patients. During the intervention refinement phase, focus groups of patients will inform refinement of the protocol and help adapt our intervention materials for behavioral weight loss, physical activity and dietary change. This randomized clinical trial (RCT) will compare augmented usual care to home-based lifestyle counseling of overweight/obese patients using an individually tailored intervention focusing on dietary and physical activity behavior change delivered by print and reinforced with supportive telephone counseling and video. Each PCP practice will receive obesity education via academic detailing supplemented by obesity management guideline implementation via a handheld device while the intervention PCP practices will receive in addition quarterly progress reports on behavioral goal attainments for each patient. The primary outcomes of the RCT will be change in BMI, physical activity and dietary changes at two years using an intent-to-treat analysis. Additional outcomes to be assessed for the RCT include: costs of the intervention and a cost-effectiveness evaluation by comparing the cost of the intervention per unit of BMI loss, as well as physical activity and diet change. By demonstrating the effectiveness of a practical lifestyle intervention with limited face-to-face contact for patients recruited from primary care practice that produces clinically meaningful changes in body mass index, physical activity, and healthy eating habits, the results of the proposed trial will have direct relevance to clinical practice. This study will fill an important gap in our knowledge regarding the translation and dissemination of research from efficacy studies to best practices in the community settings- an important objective of the NIH Roadmap Initiative. PUBLIC HEALTH RELEVANCE: This study is a cluster design clinical trial (RCT) that will demonstrate the effectiveness of a practical lifestyle intervention developed using state of the art behavioral science and with limited face-to-face contact for overweight/obese adult patients recruited from primary care practice that produces clinically meaningful changes in weight, physical activity, and healthy eating habits. The results of the proposed trial will have direct relevance to clinical practice. This study will fill an important gap in our knowledge regarding the translation and dissemination of research from efficacy studies to best practices in the community settings- an important objective of the NIH Roadmap Initiative.