GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

NCT07485673 | Recruiting

• 1 other identifier: C-UEES-25-18.1
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 1

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

Conditions

Adolescent Development; Mental Health Issue; Lifestyle Factors

Outcome Measures

Primary Outcomes (1)

• Comprehensive evaluation of the Ecuadorian adolescent's mental health

  Adherence to the six pillars of lifestyle medicine and their relationship with adolescent's mental health

  2025

Study Arms (1)

Wave 1

Administration of validated scales to assess mental health outcomes and the six pillars of Lifestyle Medicine. Anthropometric measurements. Physical activity evaluation. Blood and hair sample collection.

Other: Observational

Interventions

Observational OTHER

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.

Wave 1

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

School-aged adolescents between 14 and 19 years of age in Quito

You may qualify if:

• be between 14 and 19 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

UEF "Quito"

Quito, Pichincha, Ecuador

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and hair samples

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• José Francisco López-Gil, PhD.

  Universidad de Especialidades Espíritu Santo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director General del Centro de Investigaciones, PhD.

CONTACT

0425000950; fespinozaf@uees.edu.ec

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Reasearcher

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: September 4, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

EC (1)