Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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19 December 2016 |
Main ID: |
ISRCTN32136790 |
Date of registration:
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05/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness of an intervention on diet and physical activity, aimed at controlling the increase in childhood obesity in public schools from three Chilean regions
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Scientific title:
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Effectiveness of an intervention on diet and physical activity, aimed at controlling the increase in childhood obesity in public schools from three Chilean regions: a interventional randomised and controlled cluster study |
Date of first enrolment:
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15/03/2014 |
Target sample size:
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1655 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN32136790 |
Study type:
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Interventional |
Study design:
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Interventional randomised and controlled cluster study carried out in multiple schools (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Chile
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Nelly
Bustos |
Address:
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El Libano 5524
Macul
7810000
Santiago
Chile |
Telephone:
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+56 (0)2 2978 1436 |
Email:
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nbustos@inta.uchile.cl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children from public schools between the ages of 6 and 10 years, attending schools classed as high social vulnerability
Exclusion criteria: Children with any heart related pathologies
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Childhood obesity Nutritional, Metabolic, Endocrine Obesity
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Intervention(s)
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Intervention: 1. Healthy kiosk and nutritional education: With regards to the nutritional education there will be 16 sessions of 90 minutes each covering the eating guidelines for the Chilean population (Reference: Que rico es comer sano). The Healthy kiosk are based on the guidelines described in ?Manual de Implementación de un Espacio y Punto de Venta Saludable en Escuelas Básicas de Chile? published Bustos et.al. 2. Optimised physical activity: Physical education classes will be taught by a specialised physical education teacher. The classes will be run twice a week and will have duration of 90 minutes each with a minimum effective duration of 70 minutes during which 50% of the time children will undertake physical activity of moderate to high intensity. 3. Complete intervention combining items 1 and 2 above: Healthy kiosk, nutritional education and optimised physical activity.
Control: 1. Students in schools that are allocated as controls do not participate in any of the above interventions.
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Primary Outcome(s)
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Nutritional status: Overweight > 1 Z of BMI; Obese > 2 Z of BMI; Normal between -1 and 1 Z of BMI
Where Z score is calculated from the entire BMI distribution of the study participants. BMI is calculated by dividing the children weight (kg) by the height (m) squared. This outcome will be measured during March 2014
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Secondary Outcome(s)
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1. Waist perimeter (>= to 90th percentile) 2. Body fat percentage (>= to 90th percentile)
This outcome will be measured during November 2014.
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Source(s) of Monetary Support
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Tres Montes Lucchetti (Chile), FOSIS (Fondo de Solidaridad e Inversión Social from the Chilean Government) (Chile), Universidad de Chile
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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