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Completed

NCT Number: NCT00723853

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

9 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago GCRC (General Clinical Research Center)

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 14 weeks, 1 year, 2 years

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

    Time frame: 14 weeks, 1 year, 2 years

Secondary outcomes

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

    Time frame: 14 weeks, 1 year, 2 years

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

    Time frame: At two weekly meetings

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: REACH-OUT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2008
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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