Clinical trial NCT05002049: Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)
Official title: Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Keywords: Healthy Lifestyle
Science Interest
Adolescents
Deprived
Citizen Science
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: Harokopio University
name: City of Rotterdam
name: European Citizen Science Association
name: Erasmus Medical Center
name: Institut Investigacio Sanitaria Pere Virgili
First posted: 2021-08-12
Enrollment: 720
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Physical activity
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Snacking choices
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Sedentary time
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Youth interest in life science
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Science capital perception and interest
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Youth interest in science technology engineering and math (STEM) career.
timeFrame: Change from Baseline to end-of-study (6-month)
Secondary outcomes:
measure: Health-related behaviour
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Determinants of each of the behaviours
timeFrame: Change from Baseline to end-of-study (6-month)
Other outcomes:
measure: Family information
timeFrame: Change from Baseline to end-of-study (6-month)
measure: Sex
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Grade
timeFrame: Baseline
measure: Level of education
timeFrame: Baseline
measure: Country of birth of the child
timeFrame: Baseline
measure: Country of birth of the parents
timeFrame: Baseline
Locations:
city: Athens
country: Greece
facility: Department of Nutrition & Dietetics, School of Health Science & Education Harokopio University, 70, El Venizelou Ave,
state: Kallithea
city: Rotterdam
country: Netherlands
facility: Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box, 2040
state: The Netherlands
city: Reus
country: Spain
facility: Institut d'Investigació Sanitaria Pere i Virgili
state: Tarragona
city: Exeter
country: United Kingdom
facility: Children's Health and Exercise Research Centre, Sport and Health Sciences; College of Life and Environmental Sciences, University of Exeter
Study officials:
affiliation: University Rovira i Virgili
name: Rosa Solà, Prof.
role: PRINCIPAL_INVESTIGATOR
References: