Dietary ModificationEYTO-kidsNCT02702336
EYTO-kids-Pilot: European Youth Tackling Obesity in Adolescents and Children.
A study testing EYTO-kids in people with Dietary Modification, run by University Rovira i Virgili.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- EYTO-kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Lack of one of the inclusion criteria.
About this study
Official title: EYTO-kids: European Youth Tackling Obesity in Adolescents and Children, Una intervención Para Mejorar Los Estilos de Vida (Estudio Piloto)
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.
Read more
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.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- EYTO-kids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYTO-kidsBehavioural
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 group | Role | What they receive |
|---|---|---|
| EYTO-Kids Intervention Group | Experimental | 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. Receives: Behavioral: EYTO-kids |
| Control Group | No intervention | The control group will not receive any kind of intervention (only the assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit consumption and Physical Activity practice
Increase ≥1/day fruit consumption; Increase ≥4h/week physical activity practice
Measured: 10 months
Secondary outcomes (4)
Vegetable consumption
Consume ≥1 vegetable/day
Measured: 10 months
Sugary Drinks
Reduce sugary drinks every day
Measured: 10 months
Fast-food
Decrease to attend ≥ once/week to fast-food restaurants.
Measured: 10 months
Sedentary behaviours practice
Decrease sedentary behaviours practice
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionMar 2017
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 Dietary ModificationStudies 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
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Solà, MD, PhD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702336
- Sponsor's protocol ID
- EYTO-Kids-Pilot
- Acronym
- EYTO-kids
- Status last verified
- Jun 2017
- First submitted
- 2 Mar 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided
Publications
Bell SL, Audrey S, Cooper AR, Noble S, Campbell R. Lessons from a peer-led obesity prevention programme in English schools. Health Promot Int. 2017 Apr 1;32(2):250-259. doi: 10.1093/heapro/dau008.
PubMed 24711350Tarro L, Llaurado E, Aceves-Martins M, Morina D, Papell-Garcia I, Arola L, Giralt M, Sola R. Impact of a youth-led social marketing intervention run by adolescents to encourage healthy lifestyles among younger school peers (EYTO-Kids project): a parallel-cluster randomised controlled pilot study. J Epidemiol Community Health. 2019 Apr;73(4):324-333. doi: 10.1136/jech-2017-210163. Epub 2019 Jan 25.
PubMed 30683803
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EYTO-kids: European Youth Tackling Obesity in Adolescents and Children, Una intervención Para Mejorar Los Estilos de Vida (Estudio Piloto)
- ClinicalTrials.gov ID
- NCT02702336
- Acronym / sponsor ID
- EYTO-kids / EYTO-Kids-Pilot
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Mar 2016 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYTO-Kids Intervention Group | Experimental | Behavioral: EYTO-kidsAdolescents 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. |
| Control Group | No intervention | –The control group will not receive any kind of intervention (only the assessment). |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of one of the 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 |
|---|---|---|
| EYTO-kidsTo 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. | Behavioural | EYTO-Kids Intervention Group |
Primary outcome
Fruit consumption and Physical Activity practice
Time frame: 10 months
Increase ≥1/day fruit consumption; Increase ≥4h/week physical activity practice
4 secondary outcomes
Vegetable consumption
Time frame: 10 months
Sugary Drinks
Time frame: 10 months
Fast-food
Time frame: 10 months
Sedentary behaviours practice
Time frame: 10 months
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 27 Jun 2017.
- Background: PubMed 24711350Bell SL, Audrey S, Cooper AR, Noble S, Campbell R. Lessons from a peer-led obesity prevention programme in English schools. Health Promot Int. 2017 Apr 1;32(2):250-259. doi: 10.1093/heapro/dau008.
- Derived from this study: PubMed 30683803Tarro L, Llaurado E, Aceves-Martins M, Morina D, Papell-Garcia I, Arola L, Giralt M, Sola R. Impact of a youth-led social marketing intervention run by adolescents to encourage healthy lifestyles among younger school peers (EYTO-Kids project): a parallel-cluster randomised controlled pilot study. J Epidemiol Community Health. 2019 Apr;73(4):324-333. doi: 10.1136/jech-2017-210163. Epub 2019 Jan 25.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Dietary Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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, MD, PhD principal investigator
University Rovira i Virgili
Questions about this trial
What is this clinical trial studying?
A study testing EYTO-kids in people with Dietary Modification, run by University Rovira i Virgili.
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 4 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Fruit consumption and Physical Activity practice (time frame: 10 months). 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 NCT02702336, 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 27 Jun 2017.