REACH-OUT: Chicago Children's Diabetes Prevention Program
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Reach-Out Program, nutritional and exercise program; Reach-In Program, standard of care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children.
During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise.; This group will received standard medical care for their health condition. This includes meeting individually with a dietician to learn about diet, exercise and diabetes. This also includes developing an individualized meal plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Type 2 diabetes; African American children; African American youth; Community based; Family oriented; Obesity & Risk of type 2 diabetes