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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

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date June 27, 2017
Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
Fruit consumption and Physical Activity practice [ Time Frame: 10 months ]
Increase ≥1/day fruit consumption; Increase ≥4h/week physical activity practice
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Vegetable consumption [ Time Frame: 10 months ]
    Consume ≥1 vegetable/day
  • Sugary Drinks [ Time Frame: 10 months ]
    Reduce sugary drinks every day
  • Fast-food [ Time Frame: 10 months ]
    Decrease to attend ≥ once/week to fast-food restaurants.
  • Sedentary behaviours practice [ Time Frame: 10 months ]
    Decrease sedentary behaviours practice
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EYTO-kids-Pilot: European Youth Tackling Obesity in Adolescents and Children.
Official Title  ICMJE EYTO-kids: European Youth Tackling Obesity in Adolescents and Children, Una intervención Para Mejorar Los Estilos de Vida (Estudio Piloto)
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.

Detailed Description

Nowadays, unhealthy lifestyles are associated with some chronic diseases, especially obesity. If the improvement of healthy lifestyles occurs during childhood or adolescence, long-term effectiveness can be achieved. To improve healthy lifestyles, interventions that use strategies such as social marketing (based on commercial marketing, including 8 criteria to choice healthy options) and peer-led methodology (also known as peer education, is based in the transmission of healthy messages from peers to peers), have demonstrated effectiveness in youth health promotion.

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 pilot cluster, 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.

The intervention:

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.

All participants (intervention and control group) will respond a questionnaire composed by 4 validated questionnaires (ENkid questionnaire, AVall questionnaire, HBSC questionnaire and HABITS questionnaire).

It is expected to increase the percentage of scholars and adolescents that:

Consume 1 fruit/day (primary outcome) Consume 1 vegetable/day

Practice ≥4h/week physical activity practice (primary outcome)

And decrease the percentage of scholars and adolescents that:

Practice sedentary lifestyles Consume sugary drinks every day Attend ≥ once/week to fast-food restaurants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dietary Modification
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: EYTO-kids
  • No Intervention: Control Group
    The control group will not receive any kind of intervention (only the assessment).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2016)
810
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02702336
Other Study ID Numbers  ICMJE EYTO-Kids-Pilot
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Rosa Sola, University Rovira i Virgili
Study Sponsor  ICMJE University Rovira i Virgili
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rosa Solà, MD, PhD Universitat Rovira i Virgili
PRS Account University Rovira i Virgili
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP