REACH-OUT: Chicago Children's Diabetes Prevention Program - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00723853

Purpose

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.

Condition	Intervention
Obesity Type 2 Diabetes	Behavioral: Reach-Out Program, nutritional and exercise program Behavioral: Reach-In Program, standard of care

MedlinePlus related topics: Diabetes Exercise and Physical Fitness Obesity Obesity in Children

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	REACH-OUT: Chicago Children's Diabetes Prevention Program

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	160
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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.
Group 2: Active Comparator 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.

Arms

Assigned Interventions

Group 1: Experimental

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.

Group 2: Active Comparator

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.

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.

Eligibility

Ages Eligible for Study:	9 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723853

Contacts

Contact: Deborah Burnet, MD

773-702-4582

dburnet@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago GCRC (General Clinical Research Center)	Recruiting
Chicago, Illinois, United States, 60637
Contact: Deborah Burnet, MD 773-702-4582 dburnet@medicine.bsd.uchicago.edu
Principal Investigator: Debroah Burnet, MD
Sub-Investigator: Marshall Chin, MD
Sub-Investigator: Izadora Torres, MPH
Sub-Investigator: Sarah Wolf, MPH, RD
Sub-Investigator: Althera Steenes, Outreach Specialist

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Deborah Burnet, MD

University of Chicago

More Information

Responsible Party:	University of Chicago ( Dr. Deborah Burnet )
Study ID Numbers:	11113B
Study First Received:	July 25, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00723853
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Obesity
Type 2 diabetes
African American children
African American youth

Community based
Family oriented
Obesity & Risk of type 2 diabetes

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009