GIRLS HEALTH ENRICHMENT MULTI-SITE STUDIES (GEMS)
Principal Investigator: James Rochon, Ph.D.
The Girl's Health Enrichment Multi-site Studies (GEMS) was 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 was conducted as four inter-dependent, clinical trials. They were "inter-dependent" in the sense that they considered similar study populations, followed similar follow-up schedules and used a "core" set of evaluation procedures. Nonetheless, GEMS was not a "multi-center clinical trial" in the usual sense - each field center evaluated its own intervention (and corresponding control). As a result, each study had high internal validity and was designed and analyzed as a study in its own right.
Each study wass designed as a parallel-group, randomized, controlled study. At the Baylor College of Medicine, the University of Minnesota and Stanford University, there were two treatment arms under consideration and each study included a sample of 240 girls. The study at the University of Memphis incorporates three arms and will included 360 girls. Given the nature of the intervention and control conditions, it was not be possible to mask study participants or GEMS staff members to the treatment assignments.
Interventions provided a 24-month period and core follow-up evaluations performed at baseline, and at 12 and 24 months following randomization. Body-mass index (BMI) was 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.
This research was conducted in four distinct phases. The "developmental phase" included a formative assessment phase which used qualitative methods to understand the specific needs of this population of girls and their families. A validity and reliability study was 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" was performed prior to the main study. The purpose of the pilot was to demonstrate the feasibility of conducting this research program and to obtain data for planning the main study. The final component was the full-scale implementation of the different studies.
NIH/NHLBI Cooperative Agreement 5-U01- HL62732.)