REACH-OUT: Chicago Children's Diabetes Prevention Program

Obesity Clinical Trial

— REACH-OUT  

Official title:

REACH-OUT: Chicago Children's Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723853
• Other study ID #: 11113B
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 4, 2013
• Start date: April 2008
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago GCRC (General Clinical Research Center)	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)		14 weeks, 1 year, 2 years	No
Primary	Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)		14 weeks, 1 year, 2 years	No
Secondary	Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)		14 weeks, 1 year, 2 years	No
Secondary	Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)		At two weekly meetings	No