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Completed

NCT Number: NCT02702336

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

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.

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EYTO-kids

Behavioral

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.

Primary outcomes

  1. Fruit consumption and Physical Activity practice

    Time frame: 10 months

    Increase ≥1/day fruit consumption; Increase ≥4h/week physical activity practice

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Official study title

EYTO-kids: European Youth Tackling Obesity in Adolescents and Children, Una intervención Para Mejorar Los Estilos de Vida (Estudio Piloto)

Acronym: EYTO-kids

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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