- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03222713
School-based Program Promotion of Self-regulation in Eating Healthy and Oral Health (SRH)
17. juli 2017 opdateret af: Cleidilene Ramos Magalhães, Federal University of Health Science of Porto Alegre
School-based Program of Promotion of Self-regulation for Healthy Eating and Oral Health: Study in the Context of the School Health Program in Brazil
The Health and Education Ministries of Brazil launched the Health in School Program - PSE - in 2007.
The purpose of the PSE is twofold: articulate the actions of the education and health systems to identify risk factors and prevent them; and promote the education for health in the public elementary school system.
In the health field, the self-regulation (SR) construct can contribute to the understanding of life habits which can affect the improvement of individuals' health.
This study aims to present a school-based program, Promotion of Self-Regulation in Health (SRH), which adds the self-regulation approach to the topics of healthy eating and oral health of the PSE for elementary school.
A study of a randomized clinical trial enrolling the 5th grade students of public elementary schools from the south of Brazil is presented.
The study has two phases.
In Phase 1, teachers and health professionals will participate in a training program on SRH, and in Phase 2, they will conduct an intervention in class: Promotion of SRH.
The participants were randomly assigned into three groups: Condition I followed the PSE program, Condition II group followed the PSE and the SRH program, and the control group did not enroll in either of the health promotion programs.
For the evaluation of the study, the following measures and instruments were applied: Body Mass Index (BMI), Simplified Oral Hygiene Index (OHI-S), Previous Day Food Questionnaire (PFDQ), Declarative Knowledge for Health Instrument, Food Preference Instrument, Student´s Attitudes and Perceptions and Parents Perceptions and Influences on the Health Instrument, Food Availability and Oral Health Instrument, Self-Regulation for Health Scale, Self-Efficacy for Health Scale.
Students in the three groups will be assessed five times throughout the year: before the beginning of the intervention program, three months into intervention, six months into intervention, at the end of the intervention, and, finally, six months post intervention to check for the impact of the program on children health.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
429
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien
- Cleidilene Ramos Magalhaes
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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
9 år til 13 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Teachers must teach a 5th grade class in a public elementary school
- Health professionals must be working in a primary care unit;
- Students must be enrolled in the 5th grade in a public elementary school;
- Parents/guardians: must be responsible for a child enrolled in a 5th grade class in a public elementary school
- All participants must be volunteers and must sign the Free and Informed Consent Term or Term of Assent (parents / guardians and students);
Exclusion Criteria:
Potential participants who do not meet all the inclusion criteria, including 5th grade students with special educational needs that limit their cognitive autonomy, will be excluded from 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: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Self-regulation skills for healthy eating and oral health
Tidsramme: 3 years
|
Development of self-regulatory competencies for healthier eating and oral health in childhood.
These variables wiil be evaluated through Self-Regulation for Health Scale.
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3 years
|
Self-efficacy perception for healthy eating and oral health
Tidsramme: 3 years
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Develop increased self-efficacy perception for healthy eating and oral health care.
These variables wiil be evaluated through Self-efficacy for Health Scale.
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3 years
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Declarative Knowledge for Health
Tidsramme: 3 years
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Questions for evaluate children knowledge have about healthy eating and oral health.
Will be evaluated the numbers of correct answer.
These variable These variable wiil be evaluated through Declarative Knowledge for Health Instrument.
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3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body Mass Index
Tidsramme: 3 years
|
Numbers of students with Index of overweight, obesity and thinness in the study population.
These measure will be evaluated trough BMI.
|
3 years
|
Simplified Oral Hygiene Index - OHI-S
Tidsramme: 3 years
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Numbers and classification of Index of oral hygiene (good, regular and poor), Identified by the presence of dental plaque in the study population.
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3 years
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Food consumption information
Tidsramme: 3 years
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Seeks information from schoolchildren about the food they consumed on the day prior.
will be evaluated the food group consumed in each meals on three days of week.
These variable will evaluated by Previous Day Food Questionnaire .
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
1. juni 2015
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Forventet)
1. januar 2018
Datoer for studieregistrering
Først indsendt
17. maj 2017
Først indsendt, der opfyldte QC-kriterier
17. juli 2017
Først opslået (Faktiske)
19. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Self-regulation in health
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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