REACH-OUT: Chicago Children's Diabetes Prevention Program

NCT00723853 | Completed

• 1 other identifier: 11113B
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)

  14 weeks, 1 year, 2 years

• Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)

  14 weeks, 1 year, 2 years

Secondary Outcomes (2)

• Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)

  14 weeks, 1 year, 2 years

• Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)

  At two weekly meetings

Study Arms (2)

Group 1

EXPERIMENTAL

Reach-Out Program, Nutritional and Exercise Intervention

Behavioral: Reach-Out Program, nutritional and exercise program

Group 2

ACTIVE COMPARATOR

Reach-In Program, Standard of Care

Behavioral: Reach-Out Program, nutritional and exercise program; Behavioral: Reach-In Program, standard of care

Interventions

Reach-Out Program, nutritional and exercise program BEHAVIORAL

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 1; Group 2

Reach-In Program, standard of care BEHAVIORAL

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.

Group 2

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago GCRC (General Clinical Research Center)

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Deborah Burnet, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)