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Children Education and Cardiovascular Risk Reduction in Their Parents (CETICARP)

23. marts 2019 opdateret af: Bruno Caramelli, University of Sao Paulo

Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents

This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

520

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 05403-900
        • InCor (Heart Institute) - Hospital das Clinicas da FMUSP

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

5 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil

Exclusion Criteria:

  • children and/or parents that do not agree to participate of the study;
  • children and/or parents that are taking immunosupressive drugs;
  • parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
  • parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.

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
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Lifestyle counseling
Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention.
Adfærdsmæssigt: Educational program in cardiovascular prevention
a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
Placebo komparator: Control group
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
Adfærdsmæssigt: Lifestyle counseling
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
Tidsramme: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.
Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Sao Paulo

Samarbejdspartnere

Fundação de Amparo à Pesquisa do Estado de São Paulo

Efterforskere

  • Studiestol: Bruno Caramelli, MD, PhD, University of Sao Paulo
  • Ledende efterforsker: Luciana S Fornari, MD, PhD, University of Sao Paulo

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. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

11. august 2011

Først indsendt, der opfyldte QC-kriterier

12. august 2011

Først opslået (Skøn)

15. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2009/17450-3

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 .

Kliniske forsøg med Risikoreduktion

Kliniske forsøg med Educational program in cardiovascular prevention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner