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Recruiting

NCT Number: NCT07485673

GENESIS Project: 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

Recruiting

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UEF "Quito"

Quito, Pichincha, Ecuador

Location status: Recruiting

Location contact

Doris Quiroz, MPH

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Director General del Centro de Investigaciones, PhD.

CONTACT

[email protected]

0425000950

Sponsors and collaborators

Lead sponsor

Universidad de Especialidades Espiritu Santo

Other

Registry information

Official study title

Generating Evidence on the Needs of Ecuadorian Adolescents

Acronym: GENESIS

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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