Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
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
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Bogota
-
Bogotá, Bogota, Kolumbie
- Fundación Cardioinfantil Instituto de Cardiología
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / 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
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
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
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jaime Cespedes, MD, Fundación Cardioinfantil Instituto de Cardiología
Publikace a užitečné odkazy
Obecné publikace
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Cespedes J, Briceno G, Farkouh ME, Vedanthan R, Baxter J, Leal M, Boffetta P, Woodward M, Hunn M, Dennis R, Fuster V. Targeting preschool children to promote cardiovascular health: cluster randomized trial. Am J Med. 2013 Jan;126(1):27-35.e3. doi: 10.1016/j.amjmed.2012.04.045. Epub 2012 Oct 9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
Další identifikační čísla studie
- IM-564-2012
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .