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REACH-OUT: Chicago Children's Diabetes Prevention Program (REACH-OUT)

4 september 2013 bijgewerkt door: University of Chicago
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

131

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • University of Chicago GCRC (General Clinical Research Center)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

9 jaar tot 65 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group 1
Reach-Out Program, Nutritional and Exercise Intervention
Gedragsmatig: 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.
Actieve vergelijker: Group 2
Reach-In Program, Standard of Care
Gedragsmatig: 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.

Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Tijdsspanne: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Tijdsspanne: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Tijdsspanne: 14 weeks, 1 year, 2 years
14 weeks, 1 year, 2 years
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Tijdsspanne: At two weekly meetings
At two weekly meetings

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Chicago

Onderzoekers

  • Hoofdonderzoeker: Deborah Burnet, MD, University of Chicago

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2008

Primaire voltooiing (Werkelijk)

1 april 2012

Studie voltooiing (Werkelijk)

1 april 2012

Studieregistratiedata

Eerst ingediend

25 juli 2008

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2008

Eerst geplaatst (Schatting)

29 juli 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

5 september 2013

Laatste update ingediend die voldeed aan QC-criteria

4 september 2013

Laatst geverifieerd

1 september 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 11113B

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