STATISTICAL DESIGN OF THE CHILD AND ADOLESCENT TRIAL FOR CARDIOVASCULAR HEALTH (CATCH) - IMPLICATIONS OF CLUSTER RANDOMIZATION

This paper describes some statistical considerations for the Child and Adolescent Trial for Cardiovascular Health (CATCH), a large-scale com munity health trial sponsored by the National Heart, Lung, and Blood I nstitute. The trial involves randomization of entire schools rather th an individual students to the experimental arms. The paper discussed t he implications of this form of randomization for the design and analy sis of the trial. The power calculations and analysis plan for the tri al are presented in detail. The handling of outmigrating and inmigrati ng students is also discussed.