Tailored Lifestyle Intervention in Obese Adults within Primary Care Practice

在初级保健实践中对肥胖成人进行量身定制的生活方式干预

• 批准号: 8508929
• 负责人: CHARLES B EATON
• 金额: $ 57.95万
• 依托单位: MEMORIAL HOSPITAL OF RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508929
• 关键词: Academic Detailing; Academic Medical Centers; Adult; Behavior; Behavior Control; Behavioral; Behavioral Sciences; Blue Cross; Blue Shield; Body Weight decreased; Body mass index; Calories; Characteristics; Clinical; Clinical Trials; Clinical Trials Design; Control Groups; Counseling; Decision Making; Development; Devices; Diabetes Mellitus; Diet; Diet Habits; Dyslipidemias; Eating; Education; Effectiveness; Effectiveness of Interventions; Epidemic; Evaluation; Expert Systems; Fatty acid glycerol esters; Focus Groups; Goals; Guidelines; Health; Health Benefit; Health Insurance; Health behavior change; Home environment; Hypertension; Insurance Carriers; Intervention; Knowledge; Lead; Letters; Life Style; Link; Mediating; Medical; Monitor; Obesity; Outcome; Overweight; Participant; Patients; Phase; Physical activity; Population; Positioning Attribute; Primary Care Physician; Primary Health Care; Printing; Problem Solving; Process; Progress Reports; Protocols documentation; Provider; Psychosocial Factor; Public Health; Randomized; Randomized Clinical Trials; Recruitment Activity; Research; Resources; Risk; Self Efficacy; Social support; Staging; Stimulus; Telephone; Testing; Third-Party Payer; Translating; Translations; United States National Institutes of Health; Weight; base; behavior change; clinical practice; community setting; computerized; control trial; cost; cost effective; cost effectiveness; design; dissemination research; efficacy trial; expectation; fruits and vegetables; group intervention; improved; innovation; intervention program; lifestyle intervention; mortality; obesity management; primary care setting; primary outcome; programs; skills; success; treatment as usual; two-arm study

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.

描述(由申请人提供)：我们提出了一项随机对照整群设计的临床试验，以评估创新的、量身定做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。这项研究将分为两个阶段：阶段1-干预改进，阶段2-随机设计集群临床试验，有20个初级保健提供者和200名患者。在干预改进阶段，重点患者小组将告知改进方案，并帮助调整我们的干预材料，以适应行为减肥、体力活动和饮食变化。这项随机临床试验(RCT)将对超重/肥胖患者进行增强的日常护理与基于家庭的生活方式咨询，使用的是一种个性化的干预措施，重点是通过印刷品提供的饮食和体力活动行为改变，并通过支持性电话咨询和视频加强。每个PCP实践将通过学术详细说明接受肥胖教育，并通过手持设备辅助执行肥胖管理指南，而干预PCP实践将收到关于每个患者的行为目标实现情况的季度进展报告。随机对照试验的主要结果将是使用意向治疗分析在两年内改变BMI、体力活动和饮食变化。随机对照试验需要评估的其他结果包括：干预成本，以及通过比较每单位体重指数损失的干预成本以及体力活动和饮食变化进行的成本效益评估。通过证明对从初级保健实践招募的患者进行有限面对面接触的实际生活方式干预的有效性，该实践在体重指数、体力活动和健康饮食习惯方面产生了临床上有意义的变化，拟议的试验结果将与临床实践直接相关。这项研究将填补我们在将研究从功效研究转化和传播到社区环境中的最佳实践方面的一个重要知识空白--这是NIH路线图倡议的一个重要目标。 公共卫生相关性：这项研究是一项整群设计临床试验(RCT)，它将展示一种实用的生活方式干预的有效性，该干预使用最先进的行为科学，对从初级保健实践招募的超重/肥胖成年患者进行有限的面对面接触，从而在体重、体力活动和健康饮食习惯方面产生临床意义的变化。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将研究从功效研究转化和传播到社区环境中的最佳实践方面的一个重要知识空白--这是NIH路线图倡议的一个重要目标。