GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents (GENESIS)

March 16, 2026 updated by: José Francisco López Gil, Universidad de Especialidades Espiritu Santo

Generating Evidence on the Needs of Ecuadorian Adolescents

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Director General del Centro de Investigaciones, PhD.
  • Phone Number: 0425000950
  • Email: fespinozaf@uees.edu.ec

Study Locations

  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Recruiting
        • UEF "Quito"
        • Contact:
          • Doris Quiroz, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive evaluation of the Ecuadorian adolescent's mental health
Time Frame: 2025
Adherence to the six pillars of lifestyle medicine and their relationship with adolescent's mental health
2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Especialidades Espiritu Santo

Investigators

  • Principal Investigator: José Francisco López-Gil, PhD., Universidad de Especialidades Espiritu Santo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-UEES-25-18.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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