Background. The Child and Adolescent Trial for Cardiovascular Health (
CATCH) was the first multicenter school-based research study to employ
the fundamentals of clinical trials including the standardized protoc
ol and Manuals of Operation, a steering committee for study governance
, a distributed data system, an extensive quality control system, and
a Data and Safety Monitoring Board. Method. CATCH tested the effective
ness of changes in school lunches, physical education, smoking policy,
curricula, and family activities. Ninety-six elementary schools in fo
ur states were randomized to intervention or control conditions. The b
aseline cohort comprised 5,106 ethnically diverse third graders follow
ed through fifth grade. Results. The percentages of calories from fat
and saturated fat were reduced significantly more in the intervention
school lunches than among the controls. Significant increases in moder
ate to vigorous activity levels in existing physical education classes
mere made as well. Changes in self-reported dietary, physical activit
y, and psychosocial measures were significant. There were no significa
nt differences in the physiological measures. Measurement error was ge
nerally low for all physiologic measures except skinfolds, indicating
a high level of reliability. Across all sites, the coefficients of var
iation for lipids, height, and weight were less than 3%, whereas for s
kinfolds, they were considerably higher, ranging from 6 to 8%. Intracl
ass correlations for Lipid studies were also uniformly high at 0.99. I
nterobserver agreement scores for SOFIT were greater than 90% for 9 of
the 11 activities observed. Data entry error rates were low with less
than five errors per 1,000 fields for all forms. Conclusions. The CAT
CH results provided more scientific evidence on the importance of scho
ols in the population approach to health promotion. Many of the strate
gies used in this complex multicenter trial in the areas of design and
analysis, measurement, training, data management, and quality control
protocols might be appropriate for adoption in other studies. (C) 199
6 Academic Press, Inc.