Cardiovascular disease continues to be the leading cause of death in the United States. There has been an increasing emphasis on primary prevention, with programs directed at children being widely advocated. The proposed project is designed to evaluate the effects of school-based curricula, parental involvement, and environmental change in the schools in decreasing tobacco usage, improving diet, and increasing levels of physical activity and fitness among American children. The applicants propose to establish a coordinating center to assist four clinical centers in the development, implementation, and evaluation of the project. The Principal Investigator, Co- Principal Investigator, and other investigators and advisors at the proposed coordinating center have a large experience in coordinating collaborative studies, study design, data management, and data analysis. Among the specific tasks that they propose to carry out are the following: (1) work with investigators from the clinical centers and NIH in developing a study protocol; (2) supervise the development of data forms and a Manual of Operations; (3) coordinate and participate in activities to evaluate interventions and outcome measures; (4) establish a distributed data entry system and a system for the management of all study data; (5) establish and implement appropriate quality control procedures; (6) train clinical center personnel in all study procedures; (7) coordinate all study activities, including scheduling all meetings; (8) develop and carry out approaches for estimating cost aspects of all interventions being tested; (9) design approaches for obtaining informed consent; (10) develop and supervise the implementation of a scheme for assigning school systems to interventions; (11) develop a plan for central laboratory facilities, where needed, and oversee their function; (12) prepare and distribute all appropriate reports; (13) coordinate and participate in data analysis and manuscript preparation; and (14) perform all necessary closeout activities, including archiving of study data, at the conclusion of the project. In addition to managing the data aspects of the trial, the applicants have a considerable experience and expertise in the substantive issues that will be dealt with in the project, including preventive cardiology, dietary intervention and assessment, tobacco education, approaches for assessing physical activity and fitness in children, school-based programs, and school environmental changes to facilitate risk factor modification among young people. Thus, the coordinating center should be able to furnish a large degree of leadership for this important undertaking.
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