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Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors

17. července 2018 aktualizováno: CespedesJ_PI, Fundación Cardioinfantil Instituto de Cardiología
In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of elementary school, their parents and teachers.

Přehled studie

Postavení

Dokončeno

Detailní popis

Cardiovascular disease (CVD) is a leading cause of mortality worldwide and Colombia is not an exception. Epidemiological studies have demonstrated that CVD risk factors are identifiable in childhood and they are predictor of CDV risk in adulthood. Worldwide, CDV primary prevention that begins in childhood is identified as a strategy that decreases the burden of this disease.

Programs developed in educational communities (EC), that include in their planning and implementation students, teachers and parents, with training to food personnel, are the most effective strategies to create healthy school environments and reduce the burden of chronic diseases. However recent studies that evaluate physical activity through accelerometers have not shown effectiveness.

In 2009, the Si! program and Fundación CardioInfantil performed a randomized and controlled community trial in facilities of the Colombian Family welfare Institute, ICBF, from Usaquen locality in Bogotá, finding that a pedagogical intervention (PI) in preschool children, their parents and teachers is effective in improving knowledge, attitudes and habits towards an active lifestyle and healthy diet.

The construction of the proposed intervention is based on the best available evidence about programs, policies and practices that positively impact in healthy eating and physical activity habits in EC.

The objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers.

Typ studie

Intervenční

Zápis (Aktuální)

870

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Bogota
      • Bogotá, Bogota, Kolumbie
        • Fundación Cardioinfantil Instituto de Cardiología

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

4 roky až 8 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Private schools located in the urban area of Bogotá
  • Schools with an appropriate physical activity space and infrastructure.
  • Schools that allow the study conduction.

Exclusion Criteria:

  • Schools that have received interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the year prior to the start of the study.
  • Schools that plan to receive interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the time of follow-up of the study.
  • Schools with a history of annual dropout of their students or teachers greater than 10%.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Investigational

An education intervention was implemented in 5 schools including 516 children, 360 parents and 240 teachers.

The Pedagogical Intervention last two and a half years. In children, the intervention included class activities (1/week) and the use of educational materials for the development of pedagogical activities (posters and educative guide).

In parents included 3 workshops/year (2 hours each) about the areas of the intervention; sending healthy notes (1/month) and celebration of healthy family day (1/year).

In teachers included 3 workshops/year (2 hours each) about the areas of the intervention; planning and realization of pedagogical activities to develop with the students (1/week) and follow-up visits to school (1/month).

The educational intervention helped to increase the knowledge of attitudes, and habits of healthy lifestyle in children, parents and teachers and it was based on health promotion models and social cognitive theory, to be articulated with the Institutional Educational Project through the pedagogical component that integrates three areas, physical activity, healthy eating, and the knowledge of the body and the heart with the dynamics of the educative community.

The program covered self-care of the body and heart, healthy diet, and physical activity

Aktivní komparátor: Control

The control group consisted of 4 schools including 354 children, 305 parents and 110 teachers.

The activities in control group last two and a half years. Children received the standard curriculum in health and physical activity of the national Ministry of Education.

In parents and teachers included 3 workshops/year (2 hours each) about the first aid and accident prevention.

The control group did not receive an educational intervention in areas of physical activity, healthy eating, and the knowledge of the body and the heart. Instead, children received the standard curriculum in health and physical activity of the national Ministry of Education.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in active energy expenditure in children
Časové okno: Baseline and 2.5 years

The energy expenditure (Kilocalories/day), in children from Kindergarten to grade 2 of elementary school, generated by physical activity was evaluated using accelerometers during 4 consecutive days, 24hours/day (2 weekend days and two schooldays) through an Actiheart® 4 type accelerometer.

Possible differences between changes in active energy expenditure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.

Baseline and 2.5 years
Changes in healthy foods consumption in children
Časové okno: Baseline and 2.5 years

A food frequency survey (ENSIN 2010) was used in children from Kindergarten to grade 2 of elementary school.

Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).

Possible differences between changes in the proportion of children with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.

Baseline and 2.5 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in the Body Mass Index in children
Časové okno: Baseline and 2.5 years

Using the Quetelet index, that considers the BMI as the relationship between the body weight given in kg and the square size taken in meters.

Possible differences between changes in BMI means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.

Baseline and 2.5 years
Changes in the perimeter of the waist in children
Časové okno: Baseline and 2.5 years
Using a tape measure on the skin just above the iliac crest, in feet position. Possible differences between changes in perimeter of the waist means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Baseline and 2.5 years
Changes in total cholesterol in children
Časové okno: Baseline and 2.5 years
Possible differences between changes in total cholesterol means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Baseline and 2.5 years
Changes in triglycerides in children
Časové okno: Baseline and 2.5 years
Possible differences between changes triglycerides means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders
Baseline and 2.5 years
Changes in fasting glycemia in children
Časové okno: Baseline and 2.5 years
Possible differences between changes in fasting glycemia means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders
Baseline and 2.5 years
Change in blood pressure in children
Časové okno: Baseline and 2.5 years
Three measurements were made using a standardized technique. Possible differences between changes in both systolic and diastolic blood pressure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.
Baseline and 2.5 years
Changes in the consumption of healthy foods in teachers
Časové okno: Baseline and 2.5 years

A food frequency survey (ENSIN 2010) was used in teachers. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).

Possible differences between changes in the proportion of teachers with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.

Baseline and 2.5 years
Changes in the consumption of healthy foods in parents
Časové okno: Baseline and 2.5 years

A food frequency survey (ENSIN 2010) was used in parents. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day).

Possible differences between changes in the proportion of parents with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.

Baseline and 2.5 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jaime Cespedes, MD, Fundación Cardioinfantil Instituto de Cardiología

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2013

Primární dokončení (Aktuální)

1. prosince 2017

Dokončení studie (Aktuální)

1. prosince 2017

Termíny zápisu do studia

První předloženo

26. června 2018

První předloženo, které splnilo kritéria kontroly kvality

26. června 2018

První zveřejněno (Aktuální)

9. července 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. července 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

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NE

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Ne

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