Obesity, Type 2 Diabetes
Conditions
Keywords
Obesity, Type 2 diabetes, African American children, African American youth, Community based, Family oriented, Obesity & Risk of type 2 diabetes
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.
Interventions
BEHAVIORALReach-Out Program, nutritional and exercise program
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.
BEHAVIORALReach-In Program, standard of care
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE) | 14 weeks, 1 year, 2 years |
| Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C) | 14 weeks, 1 year, 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing) | 14 weeks, 1 year, 2 years |
| Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more) | At two weekly meetings |
Countries
United States
Outcome results
None listed