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Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors

2018年7月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

870

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Bogota
      • Bogotá、Bogota、コロンビア
        • Fundación Cardioinfantil Instituto de Cardiología

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

4年~8年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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%.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in active energy expenditure in children
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in the Body Mass Index in children
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Jaime Cespedes, MD、Fundación Cardioinfantil Instituto de Cardiología

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年2月1日

一次修了 (実際)

2017年12月1日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2018年6月26日

QC基準を満たした最初の提出物

2018年6月26日

最初の投稿 (実際)

2018年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2018年7月19日

QC基準を満たした最後の更新が送信されました

2018年7月17日

最終確認日

2018年7月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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