Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)

Healthy Lifestyle Clinical Trial

— SEEDS  

Official title:

Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002049
• Other study ID #: SEEDS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2023
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Behavioral:
• Intervention 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.

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
University Rovira i Virgili	City of Rotterdam, Erasmus Medical Center, European Citizen Science Association, Harokopio University, Institut Investigacio Sanitaria Pere Virgili, University of Exeter

Countries where clinical trial is conducted

Greece,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Change from Baseline to end-of-study (6-month)
Other	Sex	Percentage of males and females	Baseline
Other	Age	Median age of participants	Baseline
Other	Grade	Academic course	Baseline
Other	Level of education	Academic course	Baseline
Other	Country of birth of the child	Country of birth of the child	Baseline
Other	Country of birth of the parents	Country of birth of the parents	Baseline
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	Change from Baseline to end-of-study (6-month)
Secondary	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.	Change from Baseline to end-of-study (6-month)