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CompletedNCT05002049SEEDSUpdated Mar 23, 2023

Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)

An interventional study of Intervention Group in Healthy Lifestyle, sponsored by University Rovira i Virgili. Completed at 4 sites in 4 countries. Open to participants aged 13 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by University Rovira i Virgili · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
13 Years to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Lifestyle

Keywords

  • Healthy Lifestyle
  • Science Interest
  • Adolescents
  • Deprived
  • Citizen Science
03

In context

Lead sponsor

University Rovira i Virgili is the lead sponsor of 50 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria per high schools:

  • 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.

Exclusion Criteria per high schools:

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

Inclusion Criteria per participants:

  • 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.

Exclusion Criteria per participants:

  • The non-completion of one of the inclusion criteria.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
720 participants (actual)

Study arms

  • Experimental
    Citizen Science Behavioral Intervention

    The 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.

    Behavioral: Intervention Group

  • No intervention
    Control Group (No intervention)

    The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.

Interventions

  • BehavioralIntervention Group

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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.

    Time frame: 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.

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

Other outcomes

  1. Family information

    Includes questions from Health Behaviour in School Aged Children (HBSC) validated questionnaire about family, such as: family affluence scale (FAS scale ranges from 0 - low affluence to 9 high affluence), family structure and family meals and, questions about environment like the use of local green space.

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

  2. Sex

    Percentage of males and females

    Time frame: Baseline

  3. Age

    Median age of participants

    Time frame: Baseline

  4. Grade

    Academic course

    Time frame: Baseline

  5. Level of education

    Academic course

    Time frame: Baseline

  6. Country of birth of the child

    Country of birth of the child

    Time frame: Baseline

  7. Country of birth of the parents

    Country of birth of the parents

    Time frame: Baseline

07

Study locations

4 sites
  • Department of Nutrition & Dietetics, School of Health Science & Education Harokopio University, 70, El Venizelou Ave,
    Athens, Kallithea 176 71, Greece
  • Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box, 2040
    Rotterdam, The Netherlands 3000 CA, Netherlands
  • Institut d'Investigació Sanitaria Pere i Virgili
    Reus, Tarragona 43204, Spain
  • Children's Health and Exercise Research Centre, Sport and Health Sciences; College of Life and Environmental Sciences, University of Exeter
    Exeter, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002049
Lead sponsor
University Rovira i Virgili
Collaborators
University of Exeter, Harokopio University, City of Rotterdam, European Citizen Science Association, Erasmus Medical Center, Institut Investigacio Sanitaria Pere Virgili
Responsible party
Rosa Sola (Principal Investigator, University Rovira i Virgili) — Principal investigator
First posted
Aug 12, 2021
Start date
Sep 1, 2021
Primary completion
Jun 30, 2022
Completion
Jul 31, 2022
Last update
Mar 23, 2023

Study contacts

Rosa Solà, Prof.
principal investigator · University Rovira i Virgili

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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