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GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

NCT07485673 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1450

Last updated 2026-03-20

No results posted yet for this study

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

Conditions

  • Adolescent Development
  • Mental Health Issue
  • Lifestyle Factors

Interventions

OTHER

Observational

The study will include the administration of self-reported validated scales to assess adolescents's mental health outcomes and the six pillars of Lifestyle Medicine. In addition, anthropometric measurements and vital signs will be obtained, and participants' physical activity levels will be evaluated. Biological samples, including blood and hair, will also be collected for further analysis.

Sponsors & Collaborators

  • Universidad de Especialidades Espiritu Santo

    lead OTHER

Principal Investigators

  • José Francisco López-Gil, PhD. · Universidad de Especialidades Espíritu Santo

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2030-08-31
Completion
2030-08-31

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485673 on ClinicalTrials.gov