REACH-OUT: Chicago Children's Diabetes Prevention Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00723853
First received: July 25, 2008
Last updated: September 4, 2013
Last verified: September 2013

July 25, 2008
September 4, 2013
April 2008
April 2012   (final data collection date for primary outcome measure)
  • Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE) [ Time Frame: 14 weeks, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C) [ Time Frame: 14 weeks, 1 year, 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00723853 on ClinicalTrials.gov Archive Site
  • Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing) [ Time Frame: 14 weeks, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more) [ Time Frame: At two weekly meetings ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
REACH-OUT: Chicago Children's Diabetes Prevention Program
REACH-OUT: Chicago Children's Diabetes Prevention Program

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Type 2 Diabetes
  • 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.
  • Experimental: Group 1
    Reach-Out Program, Nutritional and Exercise Intervention
    Intervention: Behavioral: Reach-Out Program, nutritional and exercise program
  • Active Comparator: Group 2
    Reach-In Program, Standard of Care
    Interventions:
    • Behavioral: Reach-Out Program, nutritional and exercise program
    • Behavioral: Reach-In Program, standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
9 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00723853
11113B
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Deborah Burnet, MD University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP