This U24 application from the Wake Forest School of Medicine (WFSM) describes plans by experienced inves- tigators and staff to serve as the Data Coordinating Center (DCC) for the PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE), a N=212 trial. We will build on our successes in dozens of large, long-term trials and epidemiologic studies. Our DCC experience will help ensure success in the implementation of the PROVE Trial by overseeing all data related aspects of the trial. We have a single speci?c aim: to provide project coordination, administration, data management, and biostatistical support for the PROVE Trial. We will accomplish this aim by facilitating and guiding the protocol development process, by providing scienti?cally sound study design, excellent operational and analytical methodology, a dedicated focus on recruitment, high quality follow-up and ?delity to the intervention, monitoring safety and working with the DSMB to ensure participant safety and careful study management, working with the CCC to monitor ?eld cen- ters (i.e., Northwestern, Minnesota, and Tulane), and by leading development and maintenance of the protocols, manual of procedures (MOP), forms and other study documents. We believe that PROVE Trial will have nearly all the complexities of large multi-center studies, particularly for the DCC in standardization across sites. We have several strengths: (1) a team whose members are experts in the coordination of multi-center trials, including several that are ongoing, (2) experience with cardiovascular disease (CVD) trials including the current SPRINT trial, (3) experience with exercise and weight loss trials working with the intervention proposed in the PROVE trial, (4) speci?c project management expertise, (5) a history of ef?cient and effective communication with ?eld centers, the executive committee, and the project of?ce, and (6) success working with Dr. McDermott (of the CCC) on two prior studies (LIFE and ENRGISE). WFSM views clinical trial conduct and coordination as a scienti?c undertaking, which advances through con- tinuous evaluation and innovation. While web-based randomized controlled trials (RCTs) have been conducted for almost two decades, we will continue to develop new and innovative strategies for integrating web-based technology into daily trial activities and incorporating other methods of electronic data capture into trial man- agement. We coordinated ACCORD, which was the ?rst large-scale RCT coordinated primarily over the web. The ACCORD system has evolved into the Database for Ef?cient Administration of Clinical trial OperatioNs (DEACON) system for web-based trial management which we use for all of our studies. We are constantly in- venting and evaluating new features to add to the DEACON framework. The highly experienced and talented team at WFSM will create a state-of-the-art DCC for the PROVE trial using proven (pun intended) coordinating center models. Personnel will be available from day 1 and have long- standing working relationships across multiple NIH-funded studies.

Public Health Relevance

The PROVE Trial DCC Project Narrative Wake Forest School of Medicine proposes to serve as the data coordinating center for a three site randomized clinical trial (N=212) comparing a weight loss plus exercise intervention with an exercise only intervention in overweight and obese people with peripheral artery disease (PAD). The primary outcome is 12-month change in the 6-minute walk. We would assume responsibility for developing a web-based data management system, for overseeing quality control including conducting site visits, for analyzing data, and preparing manuscripts.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Resource-Related Research Projects--Cooperative Agreements (U24)
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Clinical Trials Review Committee (CLTR)
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Einhorn, Paula T
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Wake Forest University Health Sciences
Biostatistics & Other Math Sci
Schools of Medicine
United States
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