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

Primary Purpose

Obesity, Diet, Exercise

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active intervention
Alternative Intervention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

8 Years - 10 Years (Child)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Progreso Community Center
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Alternative Intervention

Active Intervention

Arm Description

12-week alternate intervention program focused on building self-esteem and social self-efficacy

12-week intervention program focused on dietary intake and physical activity

Outcomes

Primary Outcome Measures

The primary outcome measure will be the between-group differences in BMI and body fat.

Secondary Outcome Measures

Secondary outcomes will include dietary intake and physical activity.

Full Information

First Posted
November 21, 2008
Last Updated
October 6, 2010
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00797615
Brief Title
Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)
Acronym
GEMAS
Official Title
Project Diabetes: Weight Gain Prevention in Hispanic Girls (GEMAS Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diet, Exercise, Behavioral Research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternative Intervention
Arm Type
Placebo Comparator
Arm Description
12-week alternate intervention program focused on building self-esteem and social self-efficacy
Arm Title
Active Intervention
Arm Type
Active Comparator
Arm Description
12-week intervention program focused on dietary intake and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Active intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Alternative Intervention
Intervention Description
12-week alternative intervention addressing self-esteem, for 8-10 year old Hispanic girls and their parents (N=30 girl-parent dyads).
Primary Outcome Measure Information:
Title
The primary outcome measure will be the between-group differences in BMI and body fat.
Time Frame
After 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Secondary outcomes will include dietary intake and physical activity.
Time Frame
After 12 weeks of intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina M. Beech, DrPH, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Progreso Community Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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