Back to results

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

Primary Purpose

Obesity, Life Style

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Social marketing activities and pop-up events to promote healthy lifestyles

About this trial

This is an interventional prevention trial for Obesity focused on measuring Adolescent

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Universitat Rovira i Virgili

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles.

The control group will not received any intervention activities and social events to promote healthy lifestyles.

Outcomes

Primary Outcome Measures

Change of Fruit intake

Health Behaviour in School-aged Children (HBSC) survey

Change of Vegetable intake

Health Behaviour in School-aged Children (HBSC) survey

Change of Physical activity practice

Health Behaviour in School-aged Children (HBSC) survey

Secondary Outcome Measures

Change of Sedentary behaviour

Health Behaviour in School-aged Children (HBSC) survey

Full Information

NCT ID

NCT02157402

First Posted

May 28, 2014

Last Updated

September 28, 2021

Sponsor

University Rovira i Virgili

Collaborators

European Commission, Centro Tecnológico de Nutrición y Salud, Hospital Universitari Sant Joan de Reus, Companhia de Ideas, Komunikujeme, National Children's Bureau

1. Study Identification

Unique Protocol Identification Number

NCT02157402

Brief Title

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

Acronym

EYTO-SPAIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Rovira i Virgili

Collaborators

European Commission, Centro Tecnológico de Nutrición y Salud, Hospital Universitari Sant Joan de Reus, Companhia de Ideas, Komunikujeme, National Children's Bureau

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Life Style

Keywords

Adolescent

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

The intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

The control group will not received any intervention activities and social events to promote healthy lifestyles.

Intervention Type

Behavioral

Intervention Name(s)

Social marketing activities and pop-up events to promote healthy lifestyles

Primary Outcome Measure Information:

Title

Change of Fruit intake

Description

Health Behaviour in School-aged Children (HBSC) survey

Time Frame

Change from Baseline in fruit Intake at 2 academic years

Title

Change of Vegetable intake

Description

Health Behaviour in School-aged Children (HBSC) survey

Time Frame

Change from Baseline in vegetable Intake at 2 academic years

Title

Change of Physical activity practice

Description

Health Behaviour in School-aged Children (HBSC) survey

Time Frame

Change from Baseline in physical activity practice at 2 academic years

Secondary Outcome Measure Information:

Title

Change of Sedentary behaviour

Description

Health Behaviour in School-aged Children (HBSC) survey

Time Frame

Change from Baseline in sedentary behaviour at 2 academic years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rosa Solà Alberich, M.D., PhD

Organizational Affiliation

Centro Tecnológico de Nutrición y Salud

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitat Rovira i Virgili

City

Reus

State/Province

Tarragona

ZIP/Postal Code

43204

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

35255220

Citation

Aceves-Martins M, Llaurado E, Tarro L, Papell-Garcia I, Prades-Tena J, Kettner-Hoeberg H, Puiggros F, Arola L, Davies A, Giralt M, Sola R. "Som la Pera," a School-Based, Peer-Led Social Marketing Intervention to Engage Spanish Adolescents in a Healthy Lifestyle: A Parallel-Cluster Randomized Controlled Study. Child Obes. 2022 Dec;18(8):556-571. doi: 10.1089/chi.2021.0207. Epub 2022 Mar 7.

Results Reference

derived

PubMed Identifier

26137843

Citation

Llaurado E, Aceves-Martins M, Tarro L, Papell-Garcia I, Puiggros F, Arola L, Prades-Tena J, Montagut M, Moragas-Fernandez CM, Sola R, Giralt M. A youth-led social marketing intervention to encourage healthy lifestyles, the EYTO (European Youth Tackling Obesity) project: a cluster randomised controlled0 trial in Catalonia, Spain. BMC Public Health. 2015 Jul 3;15:607. doi: 10.1186/s12889-015-1920-1.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs