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
Study website
Contact information
Type
Scientific
Contact name
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
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
School
Study 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
Primary outcome measure
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 study start date
07/01/2013
Overall study end date
28/11/2014
Reason abandoned (if study stopped)
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(s)
Healthy volunteer
Age group
Child
Lower age limit
9 Years
Upper age limit
11 Years
Sex
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
Study participating centre
Teniente General Julio A. Roca
San Martín 620
Morón
1708
Argentina
Study participating centre
Tomás Espora
Arredondo 2465
Castelar
1708
Argentina
Study participating centre
Alte. Guillermo Brown
Rio Piedras 290
Morón
1708
Argentina
Study participating centre
José de San Martín
Maison 531
Castelar
1712
Argentina
Study participating centre
Gral. Manuel Belgrano
Gutierrez 453
Moron
1706
Argentina
Study participating centre
Monseñor Miguel de Andrea
Santa María de Oro 2547
Castelar
1712
Argentina
Study participating centre
José Hernández
Luis Antonio Beruti 488
Moron
1708
Argentina
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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