title: Statistical design of the Child and Adolescent Trial for Cardiovascular Health (CATCH): implications of cluster randomization.
abstract: This paper describes some statistical considerations for the Child and Adolescent Trial for Cardiovascular Health (CATCH), a large-scale community health trial sponsored by the National Heart, Lung, and Blood Institute. The trial involves randomization of entire schools rather than individual students to the experimental arms. The paper discussed the implications of this form of randomization for the design and analysis of the trial. The power calculations and analysis plan for the trial are presented in detail. The handling of outmigrating and immigrating students is also discussed.
authors.affiliation: Biostatistics Research Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Zucker
authors.forename: E
authors.initials: E
authors.lastname: Lakatos
authors.forename: L S
authors.initials: LS
authors.lastname: Webber
authors.forename: D M
authors.initials: DM
authors.lastname: Murray
authors.forename: S M
authors.initials: SM
authors.lastname: McKinlay
authors.forename: H A
authors.initials: HA
authors.lastname: Feldman
authors.forename: S H
authors.initials: SH
authors.lastname: Kelder
authors.forename: P R
authors.initials: PR
authors.lastname: Nader
mesh_terms: D000293:Adolescent; D002318:Cardiovascular Diseases; D002648:Child; D002784:Cholesterol / Q000097:blood; D015438:Health Behavior; D006801:Humans; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012307:Risk Factors
chemical_list: D002784:Cholesterol