Clinical trial NCT00723853: REACH-OUT: Chicago Children's Diabetes Prevention Program
Official title: REACH-OUT: Chicago Children's Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Type 2 diabetes
African American children
African American youth
Community based
Family oriented
Obesity & Risk of type 2 diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 131
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 parents or guardians who are willing to participate in these programs with the child.

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, 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.

Eligibility 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

Primary outcomes:
measure: Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
timeFrame: 14 weeks, 1 year, 2 years
measure: Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
timeFrame: 14 weeks, 1 year, 2 years
Secondary outcomes:
measure: Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
timeFrame: 14 weeks, 1 year, 2 years
measure: Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
timeFrame: At two weekly meetings
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago GCRC (General Clinical Research Center)
state: Illinois
Study officials:
affiliation: University of Chicago
name: Deborah Burnet, MD
role: PRINCIPAL_INVESTIGATOR
References: