REACH-OUT: Chicago Children's Diabetes Prevention Program

Completed · Not applicable

Conditions studied: Obesity, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00723853

Run by

University of Chicago

People needed

131

Starts

2008-04-01

Expected to finish

2012-04-01

Last updated by the study team

2013-09-05

Who can join

Age: 9 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Chicago GCRC (General Clinical Research Center) — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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