Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/10/2015
Date assigned
08/10/2015
Last edited
08/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Childhood obesity is a growing concern worldwide, which can lead to serious health problems such as diabetes, heart disease and even cancer. A study in 2007 showed that in Buenos Aires more than 25% of middle and working class children aged 10-11 were overweight. Many of these children showed unhealthy eating habits, such as skipping breakfast and not getting enough fruit and vegetables in their diet. It is important to make sure that children have a healthy, balanced diet and plenty of exercise to ensure that grow and develop properly, without becoming overweight or obese. There is evidence that its spread can be prevented and even reversed when eating and physical activity habits are improved. SALTEN is a school-based programme which aims to educate children about healthy eating, as well as encouraging them to be more active. The aim of this study is to find out whether the applying the SALTEN programme in schools can help to reduce obesity in children.

Who can participate?
Healthy children in fourth and fifth grade, who attend one of the eight participating schools.

What does the study involve?
The eight participating schools are randomly allocated into two groups. Schools in the first group (intervention group) apply the SALTEN programme, providing the children with fruit during breaks and install water fountains in the playground. A physical activity instructor is also in place to encourage children to get enough physical activity in the playground. Children attending these schools also take part in 13 lessons in which teachers educate them about healthy lifestyle choices. Children attending schools in the second group (control group) receive two classroom-based lessons, teaching them about the importance of healthy eating and getting enough exercise. Before and after the study, children are measured so that weight gain can be recorded, as well as having their eating habits and physical activity levels measured before and after the study.

What are the possible benefits and risks of participating?
A benefit of taking part in the study is that children may have a healthier lifestyle which improves their general health. There are no risks of participating in this study.

Where is the study run from?
Eight public schools located in Argentina.

When is the study starting and how long is it expected to run for?
January 2013 to November 2014

Who is funding the study?
1. The Coca Cola Foundation (USA)
2. International Life Sciences Institute (Argentina)

Who is the main contact?
1. Professor Irina Kovalskys (Scientific)
ikovalskys@ilsi.org.ar
2. Dr Cecile Rausch Herscovici (Scientific)
cecilerh@ilsi.org.ar

Trial website

www.salten.com.ar

Contact information

Type

Scientific

Primary contact

Prof Irina Kovalskys

ORCID ID

Contact details

Av. Santa Fe 1145
Buenos Aires
1059
Argentina
54 11 4816 4384
ikovalskys@ilsi.org.ar

Type

Scientific

Additional contact

Dr Cecile Rausch Herscovici

ORCID ID

http://orcid.org/0000-0002-6067-8927

Contact details

Av. Santa Fe 1145
Buenos Aires
1509
Argentina
54 11 4816 4384
cecilerh@ilsi.org.ar

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comprehensive Study for the Prevention of Obesity and Non-Communicable Chronic Disease, SALTEN!

Acronym

SALTEN

Study hypothesis

Children of public schools of Argentina, aged 9-11 years, are more likely to develop healthy eating habits and improve physical activity levels if they are exposed to culturally appropriate environmental and educational stimuli during two consecutive school years.

Ethics approval

Institutional Review Board of the Argentine Medical Association (Comité de Ética de la Asociación Médica Argentina), 19/04/2013

Study design

Multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

Obesity

Intervention

A multi-component behavioural and educational intervention aimed to improve physical activity and healthy eating habits of 4th and 5th grade boys and girls of 8 schools (4 intervention; 4 control) matched for socio demographic characteristics.

Intervention arm: Children receive daily access to fruits during school-breaks; water fountains are installed in the school playgrounds, and a physical activity (PA) instructor encourages moderate to vigorous physical activity during school breaks on playgrounds that were accordingly re-designed, painted and equipped for this goal. The educational component consists of 13 units focused on healthy lifestyle that are delivered by their teachers.

Control arm: Children receive 2 classroom workshops aimed at providing knowledge regarding healthy eating and physical activity respectively.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Anthropometric measures (weight, height, waist circumference and BMI Z-score) measured at baseline and at 18 months (end of follow-up)
1.1. Weight measured using an electronic scale to the nearest 0.1kg
1.2. Height measured with a wall-mounted stadiometer to the nearest 0.1cm
1.3. Waist circumference measured using an anthropometric tape to the nearest 0.1cm
1.4. BMI z-score calculated using the 2007 WHO reference growth charts
2. Dietary intake was measured using a modified and trans-culturally adapted version of the Child Nutrition Questionnaire at baseline and subsequently at 6, 12 and 18 months
3. Physical activity level (during school-breaks, after school, and during weekend) was assessed with the interviewer based part of a culturally adapted and modified version of the Child and Adolescent Physical Activity and Nutrition Survey at baseline, 6, 12 and 18 months

Secondary outcome measures

Dietary habits and attitudes, and level of engagement and attitudes towards physical activity measured using the self-report part of the Child Nutrition Questionnaire and the Child and Adolescent Physical Activity and Nutrition Survey at baseline, 6, 12 and 18 months.

Overall trial start date

07/01/2013

Overall trial end date

28/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children in 4t hand 5th grade (aged 9-11 years)
2. Attending participating schools
3. Received parental consent

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

It was estimated that at least 508 participants were required [n=254 for the intervention group (1 cluster), and n=254 for the control group (1 cluster)]. Expecting 20% attrition, the aim was to enrol a minimum of 317 children in each group. Even anticipating a 60 % response rate, this was deemed feasible taking into account that more than 1000 children attended the eight participating schools.

Participant exclusion criteria

1. Children with severe intellectual difficulties
2. Children with limitations to engage in physical activity
3. Children suffering from illnesses compromising nutrition or food selection
4. Children taking medication known to affect body weight

Recruitment start date

18/03/2013

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Argentina

Trial participating centre

Teniente General Julio A. Roca
San Martín 620
Morón
1708
Argentina

Trial participating centre

Tomás Espora
Arredondo 2465
Castelar
1708
Argentina

Trial participating centre

Alte. Guillermo Brown
Rio Piedras 290
Morón
1708
Argentina

Trial participating centre

José de San Martín
Maison 531
Castelar
1712
Argentina

Trial participating centre

Gral. Manuel Belgrano
Gutierrez 453
Moron
1706
Argentina

Trial participating centre

Monseñor Miguel de Andrea
Santa María de Oro 2547
Castelar
1712
Argentina

Trial participating centre

José Hernández
Luis Antonio Beruti 488
Moron
1708
Argentina

Trial participating centre

Manuel Dorrego
José María Casullo 125
Moron
1708
Argentina

Sponsor information

Organisation

International Life Sciences Institute (ILSI), Argentina

Sponsor details

Av. Santa Fe 1145
Buenos Aires
1509
Argentina
+54 11 4816 4384
ilsiarg@ilsi.org.ar

Sponsor type

Research organisation

Website

www.ilsi.org.ar

Funders

Funder type

Charity

Funder name

The Coca Cola Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

International Life Sciences Institute (ILSI) Argentina

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

An original paper under the title "Findings from SALTEN, a pilot intervention designed to improve healthy eating and recreational physical activity in public schools of Argentina" to be submitted to the International Journal of Obesity.

Intention to publish date

30/10/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes