EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain) (EYTO-SPAIN)

September 28, 2021 updated by: Rosa Sola, University Rovira i Virgili

A Youth Led Social Marketing Campaign to Encourage Healthy Lifestyles. EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)

Our hypothesis is that healthy lifestyles improvement by an intervention designed according 8 social marketing Benchmark criteria, can reduce overweight or obesity implemented by adolescents on their colleges.

The general aim of EYTO program is to improve health and well-being among adolescents who live in low socioeconomically communities, through an intervention study designed by selected adolescents with the inclusion of social marketing Benchmark criteria.

Study Overview

Detailed Description

5 adolescent coordinators (of intervention high-schools) will be trained by experts in social marketing and health promotion. This 5 selected adolescent as coordinators who will be in charge of the design of an 8 social marketing criteria intervention to implement their peers´ lifestyles.

The program has over two academic years. The participants will be followed for the duration of 2 academic years, an expected of up to 16 months.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Universitat Rovira i Virgili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent signed by parents and/or guardians.
  • Adolescents between 13 and 17 years old.

Exclusion Criteria:

- The lack of one or more inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles.
No Intervention: Control Group
The control group will not received any intervention activities and social events to promote healthy lifestyles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Fruit intake
Time Frame: Change from Baseline in fruit Intake at 2 academic years
Health Behaviour in School-aged Children (HBSC) survey
Change from Baseline in fruit Intake at 2 academic years
Change of Vegetable intake
Time Frame: Change from Baseline in vegetable Intake at 2 academic years
Health Behaviour in School-aged Children (HBSC) survey
Change from Baseline in vegetable Intake at 2 academic years
Change of Physical activity practice
Time Frame: Change from Baseline in physical activity practice at 2 academic years
Health Behaviour in School-aged Children (HBSC) survey
Change from Baseline in physical activity practice at 2 academic years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Sedentary behaviour
Time Frame: Change from Baseline in sedentary behaviour at 2 academic years
Health Behaviour in School-aged Children (HBSC) survey
Change from Baseline in sedentary behaviour at 2 academic years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rosa Solà Alberich, M.D., PhD, Centro Tecnológico de Nutrición y Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EYTO-SPAIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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