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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

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
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

In context

Lead sponsor

Universidad de Especialidades Espiritu Santo is the lead sponsor of 10 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • be between 14 and 19 years old

Exclusion criteria

Exclusion Criteria:

  • have any disorder or treatment that 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • UEF "Quito"
    Quito, Pichincha, Ecuador
    Recruiting
    • Doris Quiroz, MPH · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2025 (actual). Primary completion is estimated for Aug 2030, 59 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Mar 20, 2026
StartActual
Sep 4, 2025
Primary completionEst.
Aug 2030
CompletionEst.
Aug 2030
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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