- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002049
Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project) (SEEDS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rosa Solà, Prof.
- Phone Number: 0034 977756900
- Email: rosa.sola@urv.cat
Study Contact Backup
- Name: Elisabet Llauradó, PhD
- Phone Number: 0034 977758920
- Email: elisabet.llaurado@urv.cat
Study Locations
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Kallithea
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Athens, Kallithea, Greece, 176 71
- Department of Nutrition & Dietetics, School of Health Science & Education Harokopio University, 70, El Venizelou Ave,
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The Netherlands
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Rotterdam, The Netherlands, Netherlands, 3000 CA
- Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box, 2040
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Tarragona
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Reus, Tarragona, Spain, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
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Exeter, United Kingdom
- Children's Health and Exercise Research Centre, Sport and Health Sciences; College of Life and Environmental Sciences, University of Exeter
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Change from Baseline to end-of-study (6-month)
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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)
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Snacking choices
Time Frame: Change from Baseline to end-of-study (6-month)
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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).
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Change from Baseline to end-of-study (6-month)
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Sedentary time
Time Frame: Change from Baseline to end-of-study (6-month)
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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).
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Change from Baseline to end-of-study (6-month)
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Youth interest in life science
Time Frame: Change from Baseline to end-of-study (6-month)
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Changes in life science interest.
This outcome will be measure by STEM interest survey.
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Change from Baseline to end-of-study (6-month)
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Science capital perception and interest
Time Frame: Change from Baseline to end-of-study (6-month)
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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.
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Change from Baseline to end-of-study (6-month)
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Youth interest in science technology engineering and math (STEM) career.
Time Frame: Change from Baseline to end-of-study (6-month)
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Changes in STEM career.
This outcome will be measure by Attitude towards STEM questionnaire.
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Change from Baseline to end-of-study (6-month)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Health-related behaviour
Time Frame: Change from Baseline to end-of-study (6-month)
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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.
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Change from Baseline to end-of-study (6-month)
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Determinants of each of the behaviours
Time Frame: Change from Baseline to end-of-study (6-month)
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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.
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Change from Baseline to end-of-study (6-month)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Family information
Time Frame: Change from Baseline to end-of-study (6-month)
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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.
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Change from Baseline to end-of-study (6-month)
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Sex
Time Frame: Baseline
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Percentage of males and females
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Baseline
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Age
Time Frame: Baseline
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Median age of participants
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Baseline
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Grade
Time Frame: Baseline
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Academic course
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Baseline
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Level of education
Time Frame: Baseline
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Academic course
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Baseline
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Country of birth of the child
Time Frame: Baseline
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Country of birth of the child
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Baseline
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Country of birth of the parents
Time Frame: Baseline
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Country of birth of the parents
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rosa Solà, Prof., University Rovira i Virgili
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SEEDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing 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
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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