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

NCT00797615 | Completed

• 1 other identifier: 081057
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Diet; Exercise; Behavioral Research

Outcome Measures

Primary Outcomes (1)

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

  After 12 weeks of intervention

Secondary Outcomes (1)

• Secondary outcomes will include dietary intake and physical activity.

  After 12 weeks of intervention.

Study Arms (2)

Alternative Intervention

PLACEBO COMPARATOR

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

Behavioral: Alternative Intervention

Active Intervention

ACTIVE COMPARATOR

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

Behavioral: Active intervention

Interventions

Active intervention BEHAVIORAL

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).

Active Intervention

Alternative Intervention BEHAVIORAL

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

Alternative Intervention

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (2)

Progreso Community Center

Nashville, Tennessee, 37211, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Bettina M. Beech, DrPH, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

US (2)