GENESIS Project: Generating Evidence on the Needs of Ecua... | NCT07485673

Studies
GENESIS Project: Generating Evidence on the Needs of Ecuadorian Adolescents

NCT07485673

Sponsor

Universidad de Especialidades Espiritu Santo

Status

Recruiting

Last Update Posted

Mar 20, 2026Actual

Enrollment

1,450Estimated

Phase

Not provided

Conditions

Adolescent Development
Mental Health Issue
Lifestyle Factors

Interventions

Observational

Countries

Ecuador

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2025Actual

Primary Completion Date

Aug 2030Estimated

Completion Date

Aug 2030Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

José Francisco López Gil, Senior Reasearcher, Universidad de Especialidades Espiritu SantoPrincipal Investigator

Lead Sponsor

Universidad de Especialidades Espiritu SantoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2025

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Director General del Centro de Investigaciones, PhD.	Contact	0425000950		fespinozaf@uees.edu.ec

Overall Officials

Name	Affiliation	Role
José Francisco López-Gil, PhD.	Universidad de Especialidades Espiritu Santo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UEF "Quito"	Recruiting	Quito	Pichincha		Ecuador

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided