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EYTO-kids-Pilot: European Youth Tackling Obesity in Adolescents and Children. (EYTO-kids)

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ClinicalTrials.gov Identifier: NCT02702336
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rosa Sola, University Rovira i Virgili

Brief Summary:

The primary aim is to promote healthy lifestyles among young people, through the design and implementation of health promotion activities carried out by adolescents (12-14 years old) to scholars of primary education (8-10 years old), using social marketing and peer-led strategy.

The secondary aims are: 1) to increase fruit and vegetable consumption and physical activity practice in scholars and adolescents; 2) to reduce sedentary lifestyles, sugary drinks and fast-food in scholars and adolescents.

The EYTO-kids program is a randomized, parallel, intervention program with control group, with a 2 academic courses, 2015-2016 to 2016-2017 (10 months in total), in Reus (Spain).

To achieve the aims, social marketing and peer-led methodologies will be used at the intervention design and implementation. Adolescents from secondary education (1st /2nd ESO: Educación Secundaria Obligatoria-Obligatory Secondary Education) will design and implement activities to scholars from primary education (3rd/4th primary education).

The adolescents from the intervention group will design and implement activities to implement them in to children, and the control group will not receive any kind of intervention (only the assessment).

Participation will occur according to the randomized sample size, where a minimum of 208 adolescents (104 as intervention and 104 as control group), and 602 scholars (301 as intervention and 301 as control group) will be involved.

The inclusion criteria are: to have signed informed consent (from mother/father/guardian of the participant), to provide basic demographic data, to assist participating schools and to answer a lifestyle questionnaire.


Condition or disease Intervention/treatment Phase
Dietary Modification Behavioral: EYTO-kids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: EYTO-kids: European Youth Tackling Obesity in Adolescents and Children, Una intervención Para Mejorar Los Estilos de Vida (Estudio Piloto)
Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: EYTO-Kids Intervention Group
Adolescents will receive 16h of training (2h healthy lifestyle training, social marketing and communication, 6h to design activities, 2h session together with all intervention high-schools, 6h to practice and standardize activities) and 4h (1h/activity) to implement 4 activities in schools. The scholars will receive 4 activities designed by adolescents, focusing on: 1) increasing fruit consumption, 2) increasing vegetable consumption, 3) increasing physical activity practice and to reduce sedentary lifestyles and, 4) decreasing sugary drinks and fast-food consumption.
Behavioral: EYTO-kids
To promote healthy lifestyles among young people, through the design and implementation of health promotion activities carried out by adolescents (12-14 years old) to scholars of primary education (8-10 years old), using social marketing and peer-led strategy.

No Intervention: Control Group
The control group will not receive any kind of intervention (only the assessment).



Primary Outcome Measures :
  1. Fruit consumption and Physical Activity practice [ Time Frame: 10 months ]
    Increase ≥1/day fruit consumption; Increase ≥4h/week physical activity practice


Secondary Outcome Measures :
  1. Vegetable consumption [ Time Frame: 10 months ]
    Consume ≥1 vegetable/day

  2. Sugary Drinks [ Time Frame: 10 months ]
    Reduce sugary drinks every day

  3. Fast-food [ Time Frame: 10 months ]
    Decrease to attend ≥ once/week to fast-food restaurants.

  4. Sedentary behaviours practice [ Time Frame: 10 months ]
    Decrease sedentary behaviours practice



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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • to have signed informed consent (from mother/father/guardian of the participant)
  • to provide basic demographic data
  • to assist participating schools and,
  • to answer a lifestyle questionnaire.

Exclusion Criteria:

  • Lack of one of the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702336


Sponsors and Collaborators
University Rovira i Virgili
Investigators
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Principal Investigator: Rosa Solà, MD, PhD Universitat Rovira i Virgili
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rosa Sola, Full Professor, MD, PhD, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT02702336    
Other Study ID Numbers: EYTO-Kids-Pilot
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight