Obesity Clinical Trial
— GEMASOfficial title:
Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)
Verified date | October 2010 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Over the past 30 years obesity has reached epidemic proportions in the United States (Ogden
et al, 2006). While this epidemic affects all socioeconomic levels, certain racial/ethnic
groups such as Hispanics, are disproportionately affected by obesity and diabetes. The age
of onset of excess obesity in Hispanic females, formerly young adulthood, is now younger.
Childhood obesity poses intermediate and long-term health risks, including: type 2 diabetes,
hyperlipidemia, elevated blood pressure, and metabolic syndrome. Although biological factors
may influence a child's risk for becoming overweight, the home environment has been shown to
be a predisposing and reinforcing contextual factor for unhealthy eating and exercise
behaviors. Since parents are the primary transmitters of Hispanic cultural practices and
significantly influence their children's diet and physical activity behaviors from preschool
through high school, family-based weight-gain prevention interventions are likely to be
effective.
The goal of this implementation study is to contribute to the reduction of racial/ethnic
disparities in obesity and risk of type 2 diabetes by tailoring a recently successful
childhood obesity prevention program originally developed for African American girls to
implement and evaluate with preadolescent Hispanic girls.
Status | Completed |
Enrollment | 132 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 8 Years to 10 Years |
Eligibility |
Inclusion Criteria: - 8-10 year old Hispanic girls in Nashville - The parent or guardian must identify the girl as Hispanic - The parent or guardian must identify that the girl be at or above the 25th percentile of age- and sex-specific BMI based on the 2000 CDC growth charts or one parent/caregiver must have BMI>25 kg/m2. Exclusion Criteria: - Baseline girls' BMI>35 - Medical conditions and medications affecting growth - Conditions limiting participation in the interventions (e.g., unable to participate in routine physical education classes in school) - Conditions limiting participation in the assessments (e.g., two or more grades behind in school for reading and writing) - Other criteria (e.g., inability or failure to provide informed consent). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Progreso Community Center | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure will be the between-group differences in BMI and body fat. | After 12 weeks of intervention | No | |
Secondary | Secondary outcomes will include dietary intake and physical activity. | After 12 weeks of intervention. | No |
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