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RecruitingNCT07485673GENESISUpdated Mar 20, 2026

GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

An observational study in Adolescent Development, Mental Health Issue and Lifestyle Factors, sponsored by Universidad de Especialidades Espiritu Santo. Recruiting at 1 site in Ecuador. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Universidad de Especialidades Espiritu Santo · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,450
Ages
14 Years to 19 Years
Sex
All
01

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

02

Conditions studied

  • Adolescent Development
  • Mental Health Issue
  • Lifestyle Factors
03

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • be between 14 and 19 years old

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,450 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherObservational

    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.

05

What researchers measure

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

    Time frame: 2025

06

Study locations

1 of 1 sites recruiting
  • UEF "Quito"
    Quito, Pichincha, Ecuador
    • Doris Quiroz, MPH · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT07485673
Lead sponsor
Universidad de Especialidades Espiritu Santo
Responsible party
José Francisco López Gil (Senior Reasearcher, Universidad de Especialidades Espiritu Santo) — Principal investigator
First posted
Mar 20, 2026
Start date
Sep 4, 2025
Primary completion
Aug 2030 (estimated)
Completion
Aug 2030 (estimated)
Last update
Mar 20, 2026

Study contacts

Director General del Centro de Investigaciones, PhD.
Contact
fespinozaf@uees.edu.ec
0425000950
José Francisco López-Gil, PhD.
principal investigator · Universidad de Especialidades Espiritu Santo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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