AzTrials
AzTrials

Healthy LifestyleSEEDSNCT05002049

Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)

A study testing Intervention Group in people with Healthy Lifestyle, run by University Rovira i Virgili at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

SEEDS is a multicenter 24-month citizen science (CS) cluster randomized controlled study, with interventions conducted in four European countries acting as pilot sites: 1) Greece, 2) The Netherlands, 3) Spain and 4) The United Kingdom. Read more about this study

Who is it for?
Ages 13 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Lifestyle
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
4 sitesin 4 countries
Study dates
1 Sep 2021to 31 Jul 2022
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 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • High schools located in deprived areas. Deprived areas will be selected according to what is considered an area with a low socioeconomic level according to each country.
  • Informed consent must be signed by the responsible of each high-school.
  • Adolescents aged 13- to 15-years at baseline who attended one of the participating high schools, previously randomized.
  • Informed consent must be signed by their parents/legal guardians and by each adolescent.

Who cannot join

  • The non-completion of one of the inclusion criteria.
  • The non-completion of one of the inclusion criteria.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Greece1 site
  • Department of Nutrition & Dietetics, School of Health Science & Education Harokopio University, 70, El Venizelou Ave,

    Athens, Kallithea, 176 71

Other trials in Greece

Netherlands1 site
  • Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box, 2040

    Rotterdam, The Netherlands, 3000 CA

Other trials in Netherlands

Spain1 site
  • Institut d'Investigació Sanitaria Pere i Virgili

    Reus, Tarragona, 43204

Other trials in Spain

United Kingdom1 site
  • Children's Health and Exercise Research Centre, Sport and Health Sciences; College of Life and Environmental Sciences, University of Exeter

    Exeter

Other trials in United Kingdom

About this study

SEEDS is a multicenter 24-month citizen science (CS) cluster randomized controlled study, with interventions conducted in four European countries acting as pilot sites: 1) Greece, 2) The Netherlands, 3) Spain and 4) The United Kingdom. This project will merge CS and traditional approaches and will target high schools located in deprived neighborhoods.

The methodology, that combines CS and traditional science, could build effective cooperation between science and society to empower adolescents from low-income environments to adopt healthy lifestyles to prevent obesity, increase their interest in science and improve their critical thinking.

Read the detailed description

SEEDS is a multicenter 24-month citizen science (CS) cluster randomized controlled study, with interventions conducted in four European countries acting as pilot sites: 1) Greece, 2) The Netherlands, 3) Spain and 4) The United Kingdom. This project will merge CS and traditional approaches and will target high schools located in deprived neighborhoods.

The methodology, that combines CS and traditional science, could build effective cooperation between science and society to empower adolescents from low-income environments to adopt healthy lifestyles to prevent obesity, increase their interest in science and improve their critical thinking.

The aim is to engage teenagers on this citizen science project to collaborate in all phases of the study: problem definition, data collection, analyses and dissemination. This will empower them to change habits, thereby contributing to behavioural changes. This cluster-randomized control trial involves intervention and control high-schools from deprived areas in the Netherlands, England, Greece and Spain. Teenagers with leadership skills from intervention schools (called ambassadors) and stakeholders will participate in focus groups to gain insights on the barriers and facilitators for healthy lifestyles of teenagers, and how science could help address these. Building on the information of the focus groups, ambassadors, stakeholders and other peers will participate in a collaborative competition event where the SEEDS intervention(s) will be designed. The intervention(s) will be implemented at intervention high-schools. Outcomes in health behaviours and science literacy will be assessed by validated questionnaires at the start and end of the project.

Being tested
Intervention Group
Keywords
Healthy Lifestyle, Science Interest, Adolescents, Deprived, Citizen Science

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupBehavioural

    Teenagers with leadership skills from intervention schools (called ambassadors) and stakeholders will participate in focus groups to gain insights on the barriers and facilitators for healthy lifestyles of teenagers, and how science could help address these. Building on the information of the focus groups, ambassadors, stakeholders and other peers will participate in a collaborative competition event where the SEEDS intervention(s) will be designed. The intervention(s) will be implemented at intervention high-schools during 6 months. Outcomes in health behaviours and science literacy will be assessed by validated questionnaires at the start and end of the project.

Study groups in NCT05002049
Study groupRoleWhat they receive
Citizen Science Behavioral InterventionExperimentalThe intervention group (IG) participants will receive the whole citizen science intervention of the SEEDS project, and participants will be assessed at baseline and end-of-study.
Receives: Behavioral: Intervention Group
Control Group (No intervention)No interventionThe controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity

    Change in physical activity assessed by validated questionnaire HBSC and Physical Activity Questionnaire for Children (PAQ-C).

    HBSC: days a week physically active for a total of at least 60 minutes, frequency of exercise in free time that participants get out of breath or sweat and means of transport to go to school.

    PAQ-C: 7-day recall questionnaire that assesses participation in different physical activities, as well as activity during Physical Education, lunch break, recess, after school, in the evenings and at weekends. Each of the 9 questionnaire items is scored between 1 (low) and 5 (high physical activity), and a mean score of all items constitutes the overall PAQ score.

    Measured: Change from Baseline to end-of-study (6-month)

  2. Snacking choices

    Change in healthy snacking choices (inside and outside school). This outcome will be assessed by validated questionnaires HBSC (times per week consume healthy and unhealthy snacking choices) and Beverage Frequency Questionnaire ( 7-day food record of beverages). Additionally, questions for assessing the frequency of consumption (times per week and time frame of the day) of each type of snack (chocolates, fruit and vegs, cakes or cookies and chocolates and sweets).

    Measured: Change from Baseline to end-of-study (6-month)

  3. Sedentary time

    Change in prolonged sedentary time. This outcome will be assessed by validated questionnaire HBSC (hours/day spend watching television/ playing computer games/ on computer for purposes other than playing).

    Measured: Change from Baseline to end-of-study (6-month)

  4. Youth interest in life science

    Changes in life science interest. This outcome will be measure by STEM interest survey.

    Measured: Change from Baseline to end-of-study (6-month)

  5. Science capital perception and interest

    Changes in science capital.This outcome will be measure by Science Capital Survey, developed by Archer et al. (2015): The selection of questions includes 4 components of the total Science Capital Survey: Future science job affinity (aspirations), utility of science qualifications, valuing science and scientists, and self-efficacy in science.

    Measured: Change from Baseline to end-of-study (6-month)

  6. Youth interest in science technology engineering and math (STEM) career.

    Changes in STEM career. This outcome will be measure by Attitude towards STEM questionnaire.

    Measured: Change from Baseline to end-of-study (6-month)

Secondary outcomes (2)
  1. Health-related behaviour

    Health-related behaviour chosen by the ambassadors (each country could decide to include or not): this outcome will be decided after focus group, considering that SEEDS project is an extreme CS project, and ambassadors should be involved in the whole process and choose at least one of the three outcomes. The tool for evaluating this outcome will be developed for each country after focus groups implementation.

    Measured: Change from Baseline to end-of-study (6-month)

  2. Determinants of each of the behaviours

    According to the Theory of Planned Behaviour, the main determinants of behaviour are attitude, beliefs, subjective norms and perceived control, which all shape the behavioural intentions. For this purpose, several questions will be included to assess the determinants of behaviours, mainly related to attitudes and environmental factors, also considering the results of the focus groups, according to the guidelines.

    Measured: Change from Baseline to end-of-study (6-month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

Resources

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
Model description
High schools located in deprived areas will be randomized to the intervention group (IG) which will receive the whole citizen science intervention of the SEEDS project, or the controls group (CG) which will not receive any kind of intervention. As the high-schools will be the unit of randomization, this study is a cluster-randomized.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002049
Sponsor's protocol ID
SEEDS
Acronym
SEEDS
Status last verified
Mar 2023
First submitted
15 Jul 2021
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Metadata will be published with a DOI (Digital Object Identifier) and data will be made available upon request after signing a data transfer agreement. It may be the case that the requested data could not be shared due to confidentiality obligations. Data will only be available for those that gave consent to use data in projects other than the SEEDS project. In the metadata file will be explained what kind of data is in the dataset and how it is possible to get access to the data. This applies for the codified qualitative and quantitative data generated throughout the whole of the SEEDS project.

Publications

  • Wargers A, Senequier A, Elphick CM, Molenberg FJM, Williams CA, Llaurado E, Sola R, Manios Y, Mavrogianni C, Murray C, Jansen W, Vlachopoulos D. Adolescent perspectives on the barriers and facilitators of engagement in healthy lifestyle behaviours: a focus group study from the European SEEDS project. BMJ Open. 2026 Jun 19;16(6):e115125. doi: 10.1136/bmjopen-2025-115125.

    PubMed 42320970
  • Queral J, Mavrogianni C, Manios Y, Molenberg FJM, Jansen W, Vlachopoulos D, Williams CA, Tarro L, Llaurado E, Sola R. Impact of a participatory research intervention based on a citizen science approach on snacking consumption in European adolescents from deprived areas: a cluster randomised control trial of the SEEDS project. BMC Public Health. 2026 Mar 5;26(1):1193. doi: 10.1186/s12889-026-26877-5.

    PubMed 41787394
  • Queral J, Llaurado E, Wargers A, Jansen W, Manios Y, Senequier A, Williams CA, Vlachopoulos D, Sola R, Tarro L. Comparison of the four co-created interventions to improve snacking and physical activity behaviour in European adolescents: the SEEDS project. BMC Public Health. 2025 Mar 1;25(1):829. doi: 10.1186/s12889-025-22091-x.

    PubMed 40025539
  • Wargers A, Elphick CM, Molenberg FJM, Senequier A, Manios Y, Mavrogianni C, Murray C, Queral J, Tarro L, Williams CA, Vlachopoulos D, Jansen W. Stakeholder perspectives on the barriers and facilitators of engagement in healthy lifestyle behaviours in underrepresented adolescents: a focus group study from the European SEEDS project. BMC Public Health. 2024 Jul 25;24(1):1988. doi: 10.1186/s12889-024-19419-4.

    PubMed 39054496
  • Wargers A, Queral J, Molenberg FJ, Tarro L, Elphick CM, Kalogerakou E, Karagiannis A, Llaurado E, Manios Y, Mavrogianni C, Murray C, Vlachopoulos D, Williams CA, Jansen W, Sola R. Citizen Science to improve healthy and active living among adolescents in four European countries: a protocol of the cluster randomised controlled trial of the Science Engagement to Empower aDolescentS (SEEDS) project. BMJ Open. 2023 May 8;13(5):e070169. doi: 10.1136/bmjopen-2022-070169.

    PubMed 37156575

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Healthy Lifestyle, run by University Rovira i Virgili at 4 sites in 4 countries.

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 2 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Greece, Netherlands, Spain, United Kingdom. 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?

Physical activity (time frame: Change from Baseline to end-of-study (6-month)). The study lists 6 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 NCT05002049, which also lists 5 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 23 Mar 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in