NCT07485673 GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents
| NCT ID | NCT07485673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Especialidades Espiritu Santo |
| Condition | Adolescent Development |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,450 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,450 participants in total. It began in 2025-09-04 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Adolescence is a period of intensified emotional responses and occurs when mental health disorders commonly develop since adolescents are learning how to deal with powerful emotions. Globally, 15% of adolescents experience a mental disorder like depression or anxiety. However, adolescent mental health goes beyond mental disorders. It is state of mental well-being that allows individuals to deal with stressors, recognize their abilities, develop their activities well, and participate in society, providing a holistic approach that highlights the interplay between psychological well-being and other aspects of life. Given this perspective, a Lifestyle Medicine (LM) approach based on a multi-component framework is needed for assessing adolescents' mental health. This study aims to evaluate adolescents' (aged 14-19) mental health, identify and mitigate the risks of developing any mental health disorder as well as formulate comprehensive interventions to promote and increase their emotional wellbeing. Methods: Cross-sectional and longitudinal studies will be performed. Adolescents from Quito, Ecuador will be recruited using a simple random sampling technique. The minimum sample size is 385; however, to increase the precision of the estimates, a target sample of approximately 1000 participants will be established. Main outcome measure will be mental health using social determinants of health and lifestyle medicine factors. Conclusion: This research project will evaluate adolescents' mental health through a holistic and multiapproach evaluation and interrelate social determinants of health and lifestyle medicine variables to propose and design multidisciplinary strategies and interventions to prevent and mitigate mental health outcomes in adolescents. Additionally, the results will be useful in informing public health authorities to evaluate or modify current policies
Eligibility Criteria
Inclusion Criteria: * be between 14 and 19 years old Exclusion Criteria: * have any disorder or treatment that contraindicated physical activity or that demanded special assistance * be under some pharmacological treatment; * not be authorized by parents, caregivers, or legal guardians to participate in the research project * do not agree to take part in the research project * for volunteering retirement.
Contact & Investigator
José Francisco López-Gil, PhD.
PRINCIPAL INVESTIGATOR
Universidad de Especialidades Espiritu Santo
Frequently Asked Questions
Who can join the NCT07485673 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 19 Years, studying Adolescent Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07485673 currently recruiting?
Yes, NCT07485673 is actively recruiting participants. Contact the research team at fespinozaf@uees.edu.ec for enrollment information.
Where is the NCT07485673 trial being conducted?
This trial is being conducted at Quito, Ecuador.
Who is sponsoring the NCT07485673 clinical trial?
NCT07485673 is sponsored by Universidad de Especialidades Espiritu Santo. The principal investigator is José Francisco López-Gil, PhD. at Universidad de Especialidades Espiritu Santo. The trial plans to enroll 1,450 participants.