REACH-OUT: Chicago Children's Diabetes Prevention Program
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 9 - 65 |
| Updated: | 10/2/2013 |
| Start Date: | April 2008 |
| End Date: | April 2013 |
| Contact: | Deborah Burnet, MD |
| Email: | dburnet@medicine.bsd.uchicago.edu |
| Phone: | 773-702-4582 |
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.
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.
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
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