Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Wise Mind: Environmental Approach for Obesity Prevention

The study will be conducted in four Catholic schools with children enrolled in Grades 2 through 6. Girls and boys and children of all racial types are eligible for participation in the study. We anticipate that approximately 1,000 to 1200 children will volunteer for the study. We request enrollment of 1200 children. To participate, parents must grant written consent and the child must assent by signing a consent form that is attached. Two of the four schools that volunteer for participation in the study and are approved by the research team, will be randomly assigned to a health promotion program called "Wise Mind for Diet and Physical Activity. The other two schools will be randomly assigned to a program called "Wise Mind for Avoidance of Alcohol, Drugs, and Tobacco." Students will receive the program in the school that they attend. They will not be allowed to select one of the programs and will receive only one program, i.e., the program in their school. Both health promotion programs will last for two academic years. Each year, every child that is a research participant will be tested on two occasions, once during the first two months of school (Sept and Oct), and once during the last two months of school (March and April). Testing will not be conducted during May in order to avoid interference with school activities at the end of the academic year. All children (in all four schools) will have the same testing. The testing will involve confidential measurement of eating habits, food intake, physical activity habits, attitudes about alcohol, drugs, and tobacco, body weight and height, body fatness, body image, mood, and self-esteem. The measurement techniques that will be used for this measurement will include: questionnaires, weighing, measurement of height, and photography of foods before and after eating. All measurements will be confidential and will not be released to anyone that is not involved in the management of the study, including school personnel. The total time requirement for each testing period is expected to be approximately three hours, spread over four testing periods during a two-week period. The testing periods will be conducted in conjunction with school administrators and will not be scheduled to conflict with important school activities, classes, or academic tests. A Data and Safety Monitoring Board (DSMB) will be organized to provide oversight for the conduct of the study.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1000

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Pennington Biomedical Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • Must be a student in one of the four catholic schools in Baton Rouge that have elected to participate in the study.
  • Must be in the second through sixth grade at the start of the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2003

Primær færdiggørelse

7. december 2022

Studieafslutning

7. december 2022

Datoer for studieregistrering

Først indsendt

16. juli 2003

Først indsendt, der opfyldte QC-kriterier

17. juli 2003

Først opslået (Skøn)

18. juli 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2010

Sidst verificeret

1. januar 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • YSMIND (completed)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner