Status:
COMPLETED
REACH-OUT: Chicago Children's Diabetes Prevention Program
Lead Sponsor:
University of Chicago
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
9-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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, Inf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00723853
Start Date
April 1 2008
End Date
April 1 2012
Last Update
September 5 2013
Active Locations (1)
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1
University of Chicago GCRC (General Clinical Research Center)
Chicago, Illinois, United States, 60637