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Adolescent DevelopmentGENESISNCT07485673

GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

An observational study of Adolescent Development and Mental Health Issue, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
What is being tested?
Observational
How many people
1,450 participants
Where
1 siteEcuador
Study dates
4 Sep 2025to Aug 2030
How long will I take part?
5 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • be between 14 and 19 years old

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Director General del Centro de Investigaciones, PhD. contact

0425000950

fespinozaf@uees.edu.ec

Ecuador1 site, 1 recruiting
  • UEF "Quito"

    Quito, Pichincha

    Doris Quiroz, MPH

    Recruiting

Other trials in Ecuador

About this study

Official title: 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

Being tested
Observational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    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.

Study groups in NCT07485673
Study groupRoleWhat they receive
Wave 1Administration 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.
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start4 Sep 2025
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,450 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07485673
Sponsor's protocol ID
C-UEES-25-18.1
Acronym
GENESIS
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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