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: 8790798
• 负责人: Steven H. Belle
• 金额: $ 81.66万
• 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/8790798
• 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; Relative (related person); 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; public health relevance; research study; success; successful intervention; symposium; 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)：早期成人通过生活方式减轻体重(早期)联盟包括几个随机对照干预试验，旨在减少年轻人的体重或防止不健康的体重增加。美国7个参与站点中的每一个都开发了自己的干预措施(S)，使用了各种行为改变技术，包括年轻人使用的技术。因此，在所有研究中，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，如一些共同的测量，包括结果和数据收集方案的方面。美国国立卫生研究院内的各种机构越来越多地使用这种模式，即资助多种干预措施，使用一组共同要素测试几种健康结果的方法。这种方法具有巨大的潜力，可以通过以有意义的方式结合研究中的信息，使知识超越从个别研究研究中学到的知识。早期研究有一个资源和协调股，该股维护一个共同数据库，所有研究都向该数据库作出贡献，并为交叉研究分析提供便利。复杂的干预通常使用各种技术来改变行为，并不总是所有的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，但几乎没有关于导致干预成功的基于理论的技术的其他特异性。 可能是可用的。这项应用将使用一种创新的过程来确定跨研究的行为技术，从而成功地减肥。具体地说，要实施的方法是衡量每个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财团以前成功使用的过程。长期目标是在这组干预措施中确定导致年轻人成功减肥的基于理论的行为改变技术。该项目的另一个目标是开发、测试和传播用于在整个研究联盟中确定最有前景的技术的过程。因此，该项目的目标是确定与减肥相关的干预成分的基本发现，并将这些信息传播给科学家、医生，并最终传播给公众。