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）：通过生活方式（EARLY）联盟早期成人减肥包括几项随机对照干预试验，旨在减轻体重或防止年轻人不健康的体重增加。美国7个参与研究的研究中心都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，研究中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。这种模式，即多种干预措施的资助，以测试几种方法的健康结果使用一套共同的元素已越来越多地使用各种机构在美国国立卫生研究院。这种方法具有很大的潜力，通过以有意义的方式将研究中的信息结合起来，超越了从个别研究中所能学到的知识。早期研究有一个资源和协调股，负责维持一个共同的数据库，所有研究都对该数据库作出贡献，并促进交叉研究分析。复杂的干预通常采用各种技术进行行为矫正，并不总是所有技术都有助于干预成功。对照临床试验的最终结果可能表明，干预方案比对照条件更有效，但关于导致干预成功的基于理论的技术，几乎没有其他特异性 可能是可用的。该应用程序将使用一个创新的过程来识别导致成功减肥的研究中的行为技术。具体而言，要实施的方法是测量行为改变技术在何种程度上被每一个早期干预措施所采用，并使用这些措施与干预强度的措施，以类似的方式，以前使用的过程中成功地由另一个财团的独立，但协调的随机对照试验。长期目标是确定基于理论的行为改变技术，导致在这组干预措施中的年轻人成功减肥。该项目的另一个目标是开发、测试和传播用于确定这一研究集团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成分的基本发现，并将信息传播给科学家，医生，最终是公众。