REACH-OUT: Chicago Children's Diabetes Prevention Program
NCT00723853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131
Last updated 2013-09-05
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.
Conditions
Interventions
- BEHAVIORAL
-
Reach-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.
- BEHAVIORAL
-
Reach-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 & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Deborah Burnet, MD · University of Chicago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2012-04-30
- Completion
- 2012-04-30
Countries
- United States
Study Locations
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