Back to resultsREACH-OUT: Chicago Children's Diabetes Prevention Program (REACH-OUT)
Primary Purpose
Obesity, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reach-Out Program, nutritional and exercise program
Reach-In Program, standard of care
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Type 2 diabetes, African American children, African American youth, Community based, Family oriented, Obesity & Risk of type 2 diabetes
Eligibility Criteria
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
Sites / Locations
- University of Chicago GCRC (General Clinical Research Center)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Reach-Out Program, Nutritional and Exercise Intervention
Reach-In Program, Standard of Care
Outcomes
Primary Outcome Measures
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Secondary Outcome Measures
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00723853
Brief Title
REACH-OUT: Chicago Children's Diabetes Prevention Program
Acronym
REACH-OUT
Official Title
REACH-OUT: Chicago Children's Diabetes Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Obesity, Type 2 diabetes, African American children, African American youth, Community based, Family oriented, Obesity & Risk of type 2 diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Reach-Out Program, Nutritional and Exercise Intervention
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Reach-In Program, Standard of Care
Intervention Type
Behavioral
Intervention Name(s)
Reach-Out Program, nutritional and exercise program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reach-In Program, standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Time Frame
14 weeks, 1 year, 2 years
Title
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Time Frame
14 weeks, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Time Frame
14 weeks, 1 year, 2 years
Title
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Time Frame
At two weekly meetings
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Burnet, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago GCRC (General Clinical Research Center)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
REACH-OUT: Chicago Children's Diabetes Prevention Program
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