Cross-study analysis of coordinated randomized clinical trials for weight managem

体重管理协调随机临床试验的交叉研究分析

• 批准号: 8969694
• 负责人: Steven H. Belle
• 金额: $ 74.46万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-12-01 至 2018-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8969694
• 关键词: Address; Adult; Age; Alzheimer' s Disease; Behavior; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Caregivers; Categories; Clinical Trials; Common Data Element; Complex; Controlled Clinical Trials; Data; Data Collection; Data Element; Databases; Disease; Dose; Elements; Exclusion Criteria; Funding; Funding Agency; Goals; Health; Heterogeneity; Human Resources; Individual; Institutes; Institution; Intervention; Intervention Studies; Intervention Trial; Knowledge; Lead; Learning; Length; Life Style; Measurement; Measures; Mission; Modeling; National Heart, Lung, and Blood Institute; Obesity; Outcome; Participant; Physicians; Prevalence; Prevention; Process; Protocols documentation; Public Health; Publications; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Personnel; Resources; Risk Factors; Scientist; Site; Specificity; Strategic Planning; Target Populations; Taxonomy; Techniques; Technology; Testing; Translating; U-Series Cooperative Agreements; United States; United States National Institutes of Health; Weight; Weight Gain; Weight maintenance regimen; Work; active control; age group; arm; base; behavior change; cardiovascular disorder risk; clinical practice; comparative effectiveness; depressive symptoms; design; effective intervention; experience; group intervention; high risk; innovation; mortality; multi-component intervention; novel strategies; prevent; psychosocial; research study; self-directed learning; success; successful intervention; symposium; symptomatology; theories; trial design; young adult

 DESCRIPTION (provided by applicant): The Early Adult Reduction of weight through Lifestyle (EARLY) Consortium includes several randomized controlled intervention trials designed to reduce weight or prevent unhealthy weight gain in young adults. Each of 7 participating sites across the United States developed their own intervention(s) using a variety of behavioral change techniques and including technologies used by young adults. Thus, there is heterogeneity in the interventions across the studies. However, the investigators agreed to common elements across all of the studies such as some common measurements, including outcomes, and aspects of the data collection protocols. This model whereby multiple interventions are funded to test several approaches for a health outcome using a set of common elements has been increasingly used by various institutes within the NIH. This approach has great potential to advance knowledge beyond what could be learned from the individual research studies by combining information across studies in a meaningful way. The EARLY studies have a Resource and Coordination Unit (RCU) that maintains a common database to which all of the studies contribute and which facilitates cross-study analyses. Complex interventions commonly employ various techniques for behavior modification, and it is not always the case that all techniques contribute to intervention success. End results of controlled clinical trials may indicate that an intervention package worked better than a control condition, but little other specificity regarding the theory based techniques that led to intervention success may be available. This application will use an innovative process to identify behavioral techniques across studies that lead to successful weight loss. Specifically, the approach to be implemented is to measure the extent to which behavior change techniques are employed by each of the EARLY interventions and to use those measures in conjunction with measures of intervention intensity in a manner similar to a process previously used successfully by another consortium of independent but coordinated randomized controlled trials. The long-term objective is to identify the theory-based behavior change techniques that lead to successful weight loss in young adults in this group of interventions. Another goal of this project is to develop, test and disseminate the process used to identify the most promising techniques across this consortium of studies. Hence, the goals of this project are to identify basic discoveries about intervention components related to weight loss and to disseminate the information to scientists, physicians, and ultimately the public.

 描述（由申请人提供）：通过生活方式减轻成人早期体重（EARLY）联盟包括几项随机对照干预试验，旨在减轻年轻人的体重或预防不健康的体重增加。美国 7 个参与地点均使用各种行为改变技术（包括年轻人使用的技术）开发了自己的干预措施。因此，各项研究的干预措施存在异质性。然而，研究人员同意所有研究的共同要素，例如一些共同的测量，包括结果和数据收集协议的各个方面。美国国立卫生研究院 (NIH) 内的各个机构越来越多地使用这种模型，即资助多种干预措施，使用一组共同要素来测试多种健康结果方法。通过以有意义的方式组合跨研究的信息，这种方法具有巨大的潜力，可以超越从单个研究中学到的知识。早期研究有一个资源和协调单位（RCU），该单位维护一个公共数据库，所有研究都对该数据库做出贡献，并促进交叉研究分析。复杂的干预通常采用各种技术来改变行为，但并非所有技术都有助于干预的成功。对照临床试验的最终结果可能表明干预方案比对照条件效果更好，但导致干预成功的基于理论的技术几乎没有其他特异性 可能可用。该应用程序将使用创新流程来确定跨研究的行为技术，从而成功减肥。具体来说，要实施的方法是衡量每项早期干预措施采用行为改变技术的程度，并将这些措施与干预强度措施结合使用，其方式类似于另一个独立但协调的随机对照试验联盟先前成功使用的过程。长期目标是确定基于理论的行为改变技术，在这组干预措施中使年轻人成功减肥。该项目的另一个目标是开发、测试和传播用于确定整个研究联盟中最有前途的技术的过程。因此，该项目的目标是确定与减肥相关的干预措施的基本发现，并将这些信息传播给科学家、医生，并最终传播给公众。