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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

基本信息

批准号：
8298184
负责人：
CHARLES B EATON
金额：
$ 64.64万
依托单位：
MEMORIAL HOSPITAL OF RHODE ISLAND
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-01 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8298184
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

项目摘要

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）：我们提出了一个随机对照的集群设计的临床试验，以评估一个创新的，量身定制的生活方式干预的有效性超重和肥胖患者在初级保健实践。该研究将分为两个阶段：第一阶段-干预措施的完善，第二阶段-随机设计的群集临床试验，20个初级保健提供者和200名患者。在干预改进阶段，重点患者群体将告知方案的改进，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）将比较超重/肥胖患者的强化日常护理与家庭生活方式咨询，采用个性化定制的干预措施，重点关注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进行强化。每个PCP实践将通过学术细节接受肥胖教育，并通过手持设备补充肥胖管理指南的实施，而干预PCP实践将额外收到每个患者行为目标实现的季度进度报告。随机对照试验的主要结果将是使用意向治疗分析的两年内BMI、体力活动和饮食变化的变化。RCT评估的其他结果包括：干预成本和成本效益评估，通过比较每单位BMI损失的干预成本，以及体力活动和饮食改变。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，使体重指数、体力活动和健康饮食习惯发生具有临床意义的变化，拟议试验的结果将与临床实践直接相关。这项研究将填补一个重要的空白，我们的知识翻译和传播的研究，从疗效研究，以最佳实践在社区设置-一个重要的目标，美国国立卫生研究院路线图倡议。公共卫生相关性：本研究是一项群集设计临床试验（RCT），将证明使用最先进的行为科学开发的实用生活方式干预措施的有效性，并对从初级保健实践中招募的超重/肥胖成人患者进行有限的面对面接触，使体重、体力活动和健康饮食习惯发生具有临床意义的变化。拟议试验的结果将与临床实践直接相关。这项研究将填补一个重要的空白，我们的知识翻译和传播的研究，从疗效研究，以最佳实践在社区设置-一个重要的目标，美国国立卫生研究院路线图倡议。