Principal Investigator: James Rochon, Ph.D.

he Girl's health Enrichment Multi-site Studies (GEMS) is a collection of studies designed to develop and test interventions to prevent excessive weight gain by African-American girls as they enter and proceed through puberty. The research is being conducted as four inter-dependent, clinical trials. They are "inter-dependent" in the sense that they are considering similar study populations, following similar follow-up schedules and use a "core" set of evaluation procedures. Nonetheless, GEMS is not a "multi-center clinical trial" in the usual sense - each field center is evaluating its own intervention (and corresponding control). As a result, each study will have high internal validity and will be designed and analyzed as a study in its own right.

ach study is designed as a parallel-group, randomized, controlled study. At the Baylor College of Medicine, the University of Minnesota and Stanford University, there are two treatment arms under consideration and each study will include a sample of 240 girls. The study at the University of Memphis incorporates three arms and will include 360 girls. Given the nature of the intervention and control conditions, it will not be possible to mask study participants or GEMS staff members to the treatment assignments.

nterventions will be provided a 24-month period, and core follow-up evaluations will be performed at baseline, and at 12 and 24 months following randomization. Body-mass index (BMI) will be taken as the primary endpoint in all four studies. Secondary outcomes include anthropometric measures (e.g., waist circumference), measures of physical activity (recalled and recorded directly), diet and nutritional data (e.g., micro- and macronutrients from a 24-hr dietary recall), and behavioral and psychosocial evaluations.

his research is being conducted in 4 distinct phases. The "developmental phase" includes a formative assessment phase which uses qualitative methods to understand the specific needs of this population of girls and their families. A validity and reliability study is designed to compare two physical activity recall instruments and to determine whether a Digimax pedometer can measure physical activity as well as that provided by the CSA accelerometer device. A "pilot study" will be performed prior to the main study. The purpose of this pilot is to demonstrate the feasibility of conducting this research program and to obtain data for planning the main study. The final component is the full-scale implementation of the different studies. NHLBI Cooperative Agreement 5-U01- HL62732.