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（由适用提供）：通过生活方式（早期）财团的早期成人减轻体重的早期减轻，包括几项旨在减轻体重或预防年轻人体重不健康的随机对照干预试验。美国各地的7个参与地点中的每个地点都使用各种行为改变技术以及包括年轻人使用的技术开发了自己的干预措施。这是整个研究的干预措施的异质性。但是，研究人员同意在所有研究中都有共同的要素，例如一些共同的测量，包括结果和数据收集方案的各个方面。 NIH中的各个机构越来越多地使用了该模型，该模型已越来越多地使用了多种干预措施来测试使用一组共同元素的多种健康结果方法。这种方法具有巨大的潜力，可以通过以有意义的方式将信息结合在一起，从而超越从个人研究中学到的知识。早期的研究具有资源和协调单元（RCU），该单位维持了一个共同的数据库，所有研究都贡献了该数据库以及哪些设施进行了跨研究分析。复杂的干预措施通常采用各种技术进行行为修改，并且并非所有技术都会有助于干预成功。对照临床试验的结果可能表明，干预套件的效果比对照条件更好，但是基于理论的技术导致干预成功的技术很少 该应用程序将使用创新的过程来识别导致成功减肥的研究的行为技术。具体而言，要实施的方法是衡量每种早期干预措施采用行为改变技术的程度，并结合使用这些措施与干预强度的测量方式，类似于与以前通过另一项独立但协调的随机对照试验成功使用的过程相似的过程。长期目标是确定基于理论的行为变化技术，从而导致这组干预措施的年轻人成功体重减轻。该项目的另一个目标是开发，测试和传播用于识别该研究联盟中最有希望的技术的过程。因此，该项目的目标是确定有关与减肥有关的干预组件的基本发现，并将信息传播给科学家，医生以及最终的公众。