Type 2 Diabetes Primary Prevention for At Risk Girls

NCT00063674 | Completed Phase 2

• 1 other identifier: T2DPPG (completed)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls. The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke. Our Two Approaches:

1. 1.A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
2. 2.After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.

Conditions

Obesity; Diabetes Mellitus; Prediabetic State

Keywords

exercise; eating; dance; health education; obesity prevention; diabetes prevention; children

Interventions

Nutrition Education BEHAVIORAL

After-school dance class BEHAVIORAL

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they: * have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease) * are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids) * have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year * have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease) * are pregnant * are unable to complete the informed consent process.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Prediabetic State; Motor Activity; Health Education

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 2, 2003
• First Posted: July 3, 2003
• Study Start: April 1, 2003
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)