NCT05002049

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

July 15, 2021

Last Update Submit

March 20, 2023

Conditions

Keywords

Healthy LifestyleScience InterestAdolescentsDeprivedCitizen Science

Outcome Measures

Primary Outcomes (6)

  • 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.

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

  • 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).

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

  • 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).

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

  • Youth interest in life science

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

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

  • 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.

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

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

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

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

Secondary Outcomes (2)

  • Health-related behaviour

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

  • Determinants of each of the behaviours

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

Other Outcomes (7)

  • Family information

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

  • Sex

    Baseline

  • Age

    Baseline

  • +4 more other outcomes

Study Arms (2)

Citizen Science Behavioral Intervention

EXPERIMENTAL

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

Control Group (No intervention)

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

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.

Citizen Science Behavioral Intervention

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Athens, Kallithea, 176 71, Greece

Location

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

Rotterdam, The Netherlands, 3000 CA, Netherlands

Location

Institut d'Investigació Sanitaria Pere i Virgili

Reus, Tarragona, 43204, Spain

Location

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

Exeter, United Kingdom

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Rosa Solà, Prof.

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 12, 2021

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data from the project will be under embargo for a period of five years, or it will be immediately made available upon agreement from the SEEDS Consortium. After this period of time, and upon agreement from the Consortium members, the data will be located in a suitable online repository. At the time at which the data is made available through an online repository anyone will be able to access and use it, in keeping with the necessary regulations from the repository. Selected curated data in the SEEDS project will be made available to interested third parties or made available on data sharing platforms. Under no circumstances will data that contain any identifying information be offered. All relevant data will be codified. There are no restrictions regarding type of analyses
Access Criteria
Once a request is made, responsible members of the Consortium will be contacted to internally discuss each request. Each partner needs to approve the usage of the data collected by their institution before sharing data with other researchers. A suitable data repository will be used for the legacy storage of all the relevant data from the SEEDS project. At the time of writing, one is yet to be decided, however, one which has an existing track record of appropriate need provision will be picked. All of the data can be viewed using standard issue programs, such as any word processor for the qualitative data, and an appropriate statistical analysis software package for the quantitative data.

Locations