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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00797615
First received: November 21, 2008
Last updated: October 6, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Obesity
Diet
Exercise
Behavioral Research
Behavioral: Active intervention
Behavioral: Alternative Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • The primary outcome measure will be the between-group differences in BMI and body fat. [ Time Frame: After 12 weeks of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will include dietary intake and physical activity. [ Time Frame: After 12 weeks of intervention. ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Alternative Intervention
12-week alternate intervention program focused on building self-esteem and social self-efficacy
Behavioral: Alternative Intervention
12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
Active Comparator: Active Intervention
12-week intervention program focused on dietary intake and physical activity
Behavioral: Active intervention
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).

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).

  Eligibility

Ages Eligible for Study:   8 Years to 10 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00797615

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Progreso Community Center
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Bettina M. Beech, DrPH, MPH Vanderbilt University
  More Information

No publications provided

Responsible Party: Bettina M. Beech, DrPH, MPH, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00797615     History of Changes
Other Study ID Numbers: 081057
Study First Received: November 21, 2008
Last Updated: October 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 14, 2014