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Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)

Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00797615
Acronym
GEMAS
Enrollment
132
Registered
2008-11-25
Start date
2008-11-30
Completion date
2010-01-31
Last updated
2010-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Diet, Exercise, Behavioral Research

Brief summary

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.

Detailed description

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 (Goran et al 2003; Hale and Rupert, 2006). 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 (Arredondo et al, 2006). Two recent empirical reviews of childhood obesity interventions demonstrated the increased effectiveness of family-based approaches (Kitzmann and Beech, 2006; Summerbell et al, 2007). 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 (Snethen et al, 2007), family-based weight-gain prevention interventions are likely to be effective. The sociocultural context of Hispanic girls involves a much higher degree of interdependence among family members in Hispanic compared to White families (Schwartz, 2007). In addition to family-based approaches to pediatric obesity prevention, culturally-relevant and community-based participatory approaches have been strongly recommended by the Institute of Medicine (IOM) and the Strategic Plan for NIH Obesity Research (NIH, 2004:25). 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 preadolescence Hispanic girls. This project will be a collaborative, participatory community-academic partnership between Vanderbilt University Medical Center (VUMC), Tennessee State University (TSU) Center for Health Research, Meharry Medical College, Progreso Community Center (PCC) and the Nashville Latino Health Coalition (NLHC). Specifically, the childhood obesity prevention program called Girl's health Enrichment Multi-site Studies (GEMS) will be tailored to be culturally-appropriate and piloted in the Hispanic/Latino community in Nashville/Davidson County, Tennessee. Dr. Bettina Beech led the development of the original GEMS intervention, which was developed and pilot-tested in Memphis, Tennessee (Beech et al, 2003). We have assembled a multi-disciplinary team with expertise in pediatric obesity (Drs. Beech, Barkin, and Cook), type 2 diabetes (Dr. Tom Elasy), community-based participatory research (Drs. Beech, Barkin, Hull), Hispanic culture (Drs. Hull and Zoorob, PCC), and community engagement (NLHC, PCC, and Drs. Beech and Hull).

Interventions

12-week family-based weight gain intervention program focused on dietary intake and physical activity for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).

12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 10 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the between-group differences in BMI and body fat.After 12 weeks of intervention

Secondary

MeasureTime frame
Secondary outcomes will include dietary intake and physical activity.After 12 weeks of intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026