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Salud Integral Colombia

2019年3月21日 更新者:Valentin Fuster、Icahn School of Medicine at Mount Sinai

Salud Integral Colombia (SI! Colombia II).

In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216 children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a five month education intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the program was feasible and effective. The Si! Program will perform a new follow up of its original children cohort, now between the ages of 9 and 13 years. The original cohort will be compared to a new comparable cohort to assess baseline knowledge, attitudes and habits of healthy lifestyles in knowledge, attitudes, habits and emotions towards a healthy lifestyles . A community pedagogical intervention in healthy lifestyles on cardiovascular health will be implemented in the intervention group.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesteremia, and 5% have hypertension.

Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesterolemia, and 5% have hypertension. In May 2009, in Bogota, Colombia, was conducted a cluster randomized trial (kindergartens) in 1216 children between 3 and 6 years old, and 928 parents with the aim of evaluate a five months educational intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the intervention was feasible and effective . Finally every 1216 children "cohort Usaquén" received the intervention, performing a follow-up at 18 and 36 months showing that the changes persisted over time

In 2016 the SI! Program will perform a new follow up of this cohort, in children between 9 and 13 years old, and under the assumption that the effects of this intervention have decreased, the researchers plan to evaluate through a randomized control trial the impact of a four months community educational intervention, in the cardiovascular health of these children and in knowledge, attitudes, habits and emotions towards a healthy lifestyle. The study will include children from the Usaquen´s cohort who are contacted and children of a comparable cohort (n = 1200), in order to achieve sustainable changes in the cardiovascular health of children, that impact the burden of disease in their adulthood.

Due to the high rate of migration within the country, given the social and economic difficulties faced by many Colombians, in 2015 the study population was scattered from 1 to 15 localities and from 14 kindergartens to more than 200 public and private schools, mostly in the Usaquen´s locality, with great variability ranging from the facilities, resources, length of the school day, number of children in each classroom, to the training of teachers and their low motivation and availability time to perform any initiative (data obtained from focus groups conducted in schools). For these reasons, it is not feasible to carry out a second educational intervention in schools. However, the investigators believe that a community-based intervention is an excellent choice for tracking this population.

The objective of this project is two-fold. First, it is to assess differences at baseline in healthy lifestyles between children from Usaquen's cohort and a comparable cohort. The study will also assess differences at baseline in cardiovascular health between parents from Usaquen's cohort, and a comparable cohort. Second, it is to assess the impact of a community pedagogical intervention in healthy lifestyles in children nine to thirteen years old.

研究の種類

介入

入学 (実際)

1216

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、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

9年~13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:

  • Children 9-13 years old from the original Usaquen's cohort
  • Children 9-13 years old who are not included in the original cohort (comparable cohort)
  • Parents of participating children

Exclusion Criteria:

  • Participant unable to consent
  • Parents of non-participating children
  • Siblings of the Original Usaquen cohort's children that do not belong to the original cohort

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 will be implemented for 600 children from the original cohort (300) and comparable cohort (300) over a four month period at community centers. These sessions will occur twice a month on the weekends. The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles.
The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles. The program will cover self care of the body and heart, emotional management, healthy diet, and physical activity.
アクティブコンパレータ:Control
The control group will consist of 600 children from the original cohort (300) and comparable cohort (300). The control group will meet twice a month for four months at community centers. During these sessions, investigators will teach a curriculum that is not related to knowledge, attitudes, and habits towards healthy lifestyles.
The control will not receive an education program relating to knowledge, attitudes, nor habits of healthy lifestyles. Instead, these sessions will occur twice a month, and will last an hour and forty-five minutes. The control program is titled "Life's Challenges", which will focus on helping children develop skills necessary for day to day life, is divided into four modules: Person, Family, School, and Environment. There will be four different types of activities used throughout the program including: "Lets Think," "Lets Experiment," "We will finish with...or synthesis," and "Not here."

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 Ideal Cardiovascular Health Score (ICH)
時間枠:Baseline and 6 months
Using the metrics and criteria for individual ideal health factors and behaviors, the ideal cardiovascular health score (ICH) will be calculated for each metric (poor=0, intermediate=1, ideal=2 points; range=0-14 points for all seven metrics) and categorized them into three groups: poor (0-4 points), intermediate (5-9 points), and ideal (10-14 points). Higher values represent a better outcome.
Baseline and 6 months
Change in KAH score in Children of the Original and Comparable Cohort
時間枠:Baseline and 6 months
Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle in children will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened and control groups in the Original and comparable cohort. Possible differences between changes in means will be assessed using test t-test. Multi-variable models will be performed to adjust for potential con-founders.
Baseline and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in ICH score in Children of the Original and Comparable Cohort
時間枠:Baseline and 6 months
Mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened children in the Usaquen´s cohort and intervened children in the comparable cohort, will be determined, using a t-test. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-squared test.
Baseline and 6 months
Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort
時間枠:Baseline and 6 months
Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Multivariable models will be performed to adjust for potential confounders. Possible differences between changes in means will be assessed using a t-test.
Baseline and 6 months
Change in ICH score in Parents of the Original and Comparable Cohort
時間枠:Baseline and 6 months
In parents, mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened and control groups will be determined, using a t-test, differentiating between parents in the Usaquén´s cohort and a comparable cohort. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened and control groups differentiating between parents in the Usaquén´s cohort and a comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-square test.
Baseline and 6 months

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。

スポンサー

協力者

捜査官

  • スタディチェア:Jorge Baxter, PhD、Mobilizarte Social
  • スタディディレクター:Jaime Cespedes, MD、Fundación CardioInfantil de Cardiologia

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

2016年11月1日

一次修了 (実際)

2018年2月13日

研究の完了 (実際)

2018年2月13日

試験登録日

最初に提出

2017年3月21日

QC基準を満たした最初の提出物

2017年4月18日

最初の投稿 (実際)

2017年4月19日

学習記録の更新

投稿された最後の更新 (実際)

2019年3月25日

QC基準を満たした最後の更新が送信されました

2019年3月21日

最終確認日

2019年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • GCO 16-1354

個々の参加者データ (IPD) の計画

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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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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