REACH-OUT: Chicago Children's Diabetes Prevention Program

The University of Chicago

Status: Completed

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: Reach-In Program, standard of care; Behavioral: Reach-Out Program, nutritional and exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT00723853

11113B

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 131 patients

Sex: All

Ages: 9 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

Group 1

Experimental group

Description:

Reach-Out Program, Nutritional and Exercise Intervention

Treatment:

Behavioral: Reach-Out Program, nutritional and exercise program

Group 2

Active Comparator group

Description:

Reach-In Program, Standard of Care

Treatment:

Behavioral: Reach-In Program, standard of care

Behavioral: Reach-Out Program, nutritional and exercise program