We review recent developments in the design and analysis of group-randomized trials (GRTs). Regarding design, we summarize developments in estimates of intraclass correlation, power analysis, matched designs, designs involving one group per condition, and designs in which individuals are randomized to receive treatments in groups. Regarding analysis, we summarize developments in marginal and conditional models, the sandwich estimator, model-based estimators, binary data, survival analysis, randomization tests, survey methods, latent variable methods and nonlinear mixed models, time series methods, global tests for multiple endpoints, mediation effects, missing data, trial reporting, and software. We encourage investigators who conduct GRTs to become familiar with these developments and to collaborate with methodologists who can strengthen the design and analysis of their trials.
Researchers are encouraged to take advantage of software to implement missing value imputation, as estimates of activity are more precise and less biased in the presence of intermittent missing accelerometer data than those derived from an observed data analysis approach.
Planning a group‐randomized trial is a complex process. Care must be taken to delineate the research question, to create the research team, to plan the research design, to avoid potential design and analytic problems, to select variables of interest and their measures, to plan the intervention, and to ensure adequate power. Failure in any of these areas may lead to a dissappointing result; attention to each will increase the likelihood of success
OBJECTIVES: A randomized school based trial sought to increase fruit and vegetable consumption among children using a multicomponent approach. METHODS: The intervention, conducted in 20 elementary schools in St. Paul, targeted a multiethnic group of children who were in the fourth grade in spring 1995 and the fifth grade in fall 1995. The intervention consisted of behavioral curricula in classrooms, parental involvement, school food service changes, and industry support and involvement. Lunchroom observations and 24-hour food recalls measured food consumption. Parent telephone surveys and a health behavior questionnaire measured psychosocial factors. RESULTS: The intervention increased lunchtime fruit consumption and combined fruit and vegetable consumption, lunchtime vegetable consumption among girls, and daily fruit consumption as well as the proportion of total daily calories attributable to fruits and vegetables. CONCLUSIONS: Multicomponent school-based programs can increase fruit and vegetable consumption among children. Greater involvement of parents and more attention to increasing vegetable consumption, especially among boys, remain challenges in future intervention research.
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