REACH-OUT: Chicago Children's Diabetes Prevention Program (REACH-OUT)

September 4, 2013 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago GCRC (General Clinical Research Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Reach-Out Program, Nutritional and Exercise 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.
Active Comparator: Group 2
Reach-In Program, Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Time Frame: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Time Frame: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Time Frame: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Time Frame: At two weekly meetings
At two weekly meetings

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Deborah Burnet, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11113B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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