GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-19
SponsorUniversidad de Especialidades Espiritu Santo

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

be between 14 and 19 years old

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational

    Other intervention

    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.

Treatment groups

1,450 Participants
are divided into 1 treatment group
Group A: Wave 11 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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