Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Obesity (being very overweight) among children is considered one of the most important public health problems in Chile. It is caused by eating food that is high in calories, sugars, fats and salts and is most commonly seen in children from poorer backgrounds (low socio-economic areas). Children that are obese are much more likely to develop serious health problems as adults, such as heart disease, diabetes and some forms of cancer. It can also lead to low self-esteem, lack of confidence and the development of eating disorders. There is evidence to suggest that controlling food intake and physical activity in schools is a good way to tackle childhood obesity. With that in mind, we are looking at how teaching children about good nutrition (nutritional education) and giving them specialised physical education classes may prevent childhood obesity among children from low socio-economic areas.

Who can participate?
Children between 6 and 10 years of age attending schools in low socio-economic areas.

What does the study involve?
The study is carried out over the course of one school year. It involves 12 schools with a total of 1,655 children in grades 1 to 4. Each school is randomly allocated into one of four groups, resulting in three schools being allocated to each group. Schools in group 1 are provided with a “Healthy Kiosk” from which nutritional education sessions take place. Schools in group 2 are provided with physical education classes taught by a specialised teacher. Schools in group 3 are provided with the “Healthy Kiosk” and both the nutritional education and physical education sessions. Schools in group 4 are in the control group and not provided with the “Healthy Kiosk”, nutritional education sessions or physical education sessions.

What are the possible benefits and risks of participating?
The immediate benefit of this study for the participants will be learning about how healthy their diet is and how fit they are. In the long term, this study should provide scientific evidence to influence political decisions related to public health. The main risks are involved with the physical education classes in the form of falls and minor injuries.

Where is the study run from?
Institute of Nutrition and Food Technology (Instituto de Nutrición y Técnologia de los Alimentos, or INTA), University of Chile (Chile)

When is the study starting and how long is it expected to run for?
March 2014 to December 2014

Who is funding the study?
1. Tres Montes Lucchetti (Chile)
2. FOSIS (Fondo de Solidaridad e Inversión Social from the Chilean Government) (Chile)
3. University of Chile (Universidad de Chile) (Chile)

Who is the main contact?
Nelly Bustos

Trial website

Contact information



Primary contact

Ms Nelly Bustos


Contact details

El Libano 5524
+56 (0)2 2978 1436

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

Integrated interventions that address nutrition education, the implementation of a healthy kiosk and 4 hours per week of physical education classes in different blocks, where 50% of the time corresponds to physical activity of moderate to vigorous intensity, are more effective than each of these interventions separately for the control of childhood obesity in children between the ages of 6 and 10 years of age during a school year.

Ethics approval

Institute of Nutrition and Food Technology (Instituto de Nutrición y Tecnología de los Alimentos), 12/05/2014, ref. Acta de Aprobacion Numero 5

Study design

Interventional randomised and controlled cluster study carried out in multiple schools

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet



Childhood obesity


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
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.

1. Students in schools that are allocated as controls do not participate in any of the above interventions.

Intervention type



Not Applicable

Drug names

Primary outcome measure

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

Secondary outcome measures

1. Waist perimeter (>= to 90th percentile)
2. Body fat percentage (>= to 90th percentile)

This outcome will be measured during November 2014.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Children from public schools between the ages of 6 and 10 years, attending schools classed as high social vulnerability

Participant type


Age group




Target number of participants

1,655 children

Participant exclusion criteria

Children with any heart related pathologies

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

El Libano 5524

Sponsor information


Institute of Nutrition and Food Technology (Instituto de Nutrición y Técnologia de los Alimentos) (Chile)

Sponsor details

c/o Christian Aliste
Dirección INTA Universidad de Chile
+56 (0)2 2978 1411

Sponsor type




Funder type


Funder name

Tres Montes Lucchetti (Chile)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

FOSIS (Fondo de Solidaridad e Inversión Social from the Chilean Government) (Chile)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Universidad de Chile

Alternative name(s)

University of Chile

Funding Body Type

government organisation

Funding Body Subtype

Local government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 protocol in:

Publication citations

Additional files

Editorial Notes

05/12/2016: Publication reference added.