ObesityEYTO-SPAINNCT02157402
EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)
A study testing Social marketing activities and pop-up events to promote healthy lifestyles in people with Obesity and Life Style, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Life Style
- What is being tested?
- Social marketing activities and pop-up events to promote healthy lifestyles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent signed by parents and/or guardians.
- Adolescents between 13 and 17 years old.
Who cannot join
- The lack of one or more inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Life Style
- Being tested
- Social marketing activities and pop-up events to promote healthy lifestyles
- Keywords
- Adolescent
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social marketing activities and pop-up events to promote healthy lifestylesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles. Receives: Behavioral: Social marketing activities and pop-up events to promote healthy lifestyles |
| Control Group | No intervention | The control group will not received any intervention activities and social events to promote healthy lifestyles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fruit intake
Health Behaviour in School-aged Children (HBSC) survey
Measured: Change from Baseline in fruit Intake at 2 academic years
Change of Vegetable intake
Health Behaviour in School-aged Children (HBSC) survey
Measured: Change from Baseline in vegetable Intake at 2 academic years
Change of Physical activity practice
Health Behaviour in School-aged Children (HBSC) survey
Measured: Change from Baseline in physical activity practice at 2 academic years
Secondary outcomes (1)
Change of Sedentary behaviour
Health Behaviour in School-aged Children (HBSC) survey
Measured: Change from Baseline in sedentary behaviour at 2 academic years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Centro Tecnológico de Nutrición y Salud, Hospital Universitari Sant Joan de Reus, Companhia de Ideas, Komunikujeme, National Children's Bureau
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Solà Alberich, M.D., PhD, Principal investigator, Centro Tecnológico de Nutrición y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157402
- Sponsor's protocol ID
- EYTO-SPAIN
- Acronym
- EYTO-SPAIN
- Status last verified
- Sep 2021
- First submitted
- 28 May 2014
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35255220Llaurado 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.
PubMed 26137843
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Youth Led Social Marketing Campaign to Encourage Healthy Lifestyles. EYTO (European Youth Tackling Obesity): A Randomized Controlled Trial in Catalonia (Spain)
- ClinicalTrials.gov ID
- NCT02157402
- Acronym / sponsor ID
- EYTO-SPAIN / EYTO-SPAIN
- Conditions
- Obesity, Life Style
- Keywords
- Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- European Commission, Centro Tecnológico de Nutrición y Salud, Hospital Universitari Sant Joan de Reus, Companhia de Ideas, Komunikujeme, National Children's Bureau
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Social marketing activities and pop-up events to promote healthy lifestylesThe intervention group will received activities and social events designed according 8 social marketing Benchmark criteria to promote healthy lifestyles. |
| Control Group | No intervention | –The control group will not received any intervention activities and social events to promote healthy lifestyles. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Informed consent signed by parents and/or guardians.
- Adolescents between 13 and 17 years old.
Key exclusion criteria (1 listed)
- The lack of one or more inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social marketing activities and pop-up events to promote healthy lifestyles | Behavioural | Intervention Group |
Primary outcome
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 of Vegetable intake
Time frame: Change from Baseline in vegetable Intake at 2 academic years
Health Behaviour in School-aged Children (HBSC) survey
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
1 secondary outcome
Change of Sedentary behaviour
Time frame: Change from Baseline in sedentary behaviour at 2 academic years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 35255220Aceves-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.
- Derived from this study: PubMed 26137843Llaurado 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà Alberich, M.D., PhD principal investigator
Centro Tecnológico de Nutrición y Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social marketing activities and pop-up events to promote healthy lifestyles in people with Obesity and Life Style, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Fruit intake (time frame: Change from Baseline in fruit Intake at 2 academic years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.