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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. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN16804726 |
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Date of registration:
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08/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Jumping to Health
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Scientific title:
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Comprehensive Study for the Prevention of Obesity and Non-Communicable Chronic Disease, SALTEN! |
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Date of first enrolment:
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18/03/2013 |
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Target sample size:
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508 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN16804726 |
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Study type:
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Interventional |
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Study design:
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Multi-centre cluster randomised controlled trial (Prevention)
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Phase:
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Countries of recruitment
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Argentina
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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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Irina
Kovalskys |
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Address:
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Av. Santa Fe 1145
1059
Buenos Aires
Argentina |
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Telephone:
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54 11 4816 4384 |
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Email:
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ikovalskys@ilsi.org.ar |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children in 4t hand 5th grade (aged 9-11 years)
2. Attending participating schools
3. Received parental consent
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
Nutritional, Metabolic, Endocrine
Obesity
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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The Coca Cola Foundation, International Life Sciences Institute (ILSI) Argentina
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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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