Expired Study
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Chicago, Illinois 60637


Purpose:

The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.


Study summary:

This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children [WIC] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation). All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.


Criteria:

Inclusion Criteria: - Overweight (>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects. Exclusion Criteria: - Inability to give informed consent or unwillingness to be randomized - Prior diagnosis of diabetes in the child planning to participate - Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions). - Uncontrolled hypertension (SBP> 160 or DBP>100) (JNC V, 1993) - Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001) - Evidence of significant cardiovascular, pulmonary disease, or other serious illness - Evidence of alcohol or drug abuse (identified by self-report) - Musculoskeletal disease serious enough to prevent participation in exercise sessions - Known or suspected major psychiatric disorder - Inability to participate in aerobic exercise activities - Inability to comply with a calorie or fat restricted diet - Age over 65 years


NCT ID:

NCT00723853


Primary Contact:

Principal Investigator
Deborah Burnet, MD
University of Chicago


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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