Girls Health Enrichment Multi-Site Studies (GEMS)
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To develop and test interventions to prevent obesity by decreasing weight gain during the
      high-risk transitional period from pre-puberty to puberty in African-American girls who are
      at high risk for developing obesity.
    

Detailed description: 
      BACKGROUND:

      The high prevalence of obesity in Black women may be a contributing factor to their higher
      mortality from cardiovascular disease and higher prevalence of diabetes and hypertension
      compared with white and Hispanic women. Although Hispanic women also exhibit high prevalence
      of obesity, mortality from heart disease is less than for Black or white women and mortality
      from diabetes is less than for Black women.

      The increased prevalence of obesity in Black females is present during childhood, and the
      prevalence of obesity is increasing faster in Black girls than in white girls. Recent data
      from the third National Health and Nutrition Examination Survey (NHANES III) showed that
      during preadolescence, age 6-11 years, 30.7 percent of Black girls, compared with 22.0
      percent of white girls, were overweight. Furthermore, over the past 30 years the prevalence
      of obesity in this preadolescent age group has increased 150 percent in Black girls compared
      with 40 percent in white girls. The prevalence of obesity in the adolescent age of 12 to 17
      years is similarly high, at 29.9 percent in Black girls compared with 20.7 percent in white
      girls. The 35 percent increase in obesity over the past 30 years is similar in the
      preadolescent and adolescent age groups for white girls, but for Black girls the increase is
      greater in the younger age group (150 percent more prevalent) than in the older age group (80
      percent increase) .

      The Special Emphasis Panel (SEP) on Intervention Studies in Children and Adolescents to
      Prevent Cardiovascular Disease was convened in September 1997 to review the efficacy and
      effectiveness of interventions to prevent and improve known cardiovascular disease risk
      factors in children and adolescents and to develop recommendations for future preventive
      intervention studies. The initiative was developed in response to recommendations of the SEP.
      The RFA was released in April 1998.

      DESIGN NARRATIVE:

      The 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.

      In Phase I, several distinct and separate interventions were developed. Interventions
      addressed diet, physical activity, and psychosocial and familial influences. There were four
      participating centers in Phase I, including the University of Memphis, Stanford University,
      the University of Minnesota, and Baylor College of Medicine. The coordinating center was
      located at George Washington University.

      In Phase II, individual clinical trials will be supported to test the efficacy of
      interventions developed in Phase I. Although the interventions developed by each field center
      will be unique, the centers will collaborate to standardize key measurements, outcomes, and
      main analysis methods. The Memphis Field Center will conduct a full-scale two year,
      randomized, controlled clinical trial for weight gain prevention among 300 high risk,
      preadolescent African American girls and their parents. Body mass index is the primary
      endpoint. Secondary endpoints include dietary intake, physical activity, and psychosocial
      variables. The Stanford Field Center will conduct a two-arm parallel group, randomized
      controlled trial to test the efficacy of an after school dance program and a family-based
      intervention to reduce television, videotape, and video game use to reduce weight gain among
      260 African American preadolescent girls. An active placebo group will receive an
      information-based community health education intervention. Interventions will last for two
      years. Body mass index is the primary outcome measure.
    

Intervention name(s): diet, reducing
Intervention type(s): Behavioral
Primary purpose: Prevention