Effect of the WAIO Digital Platform on Multidimensional Wellbeing in Adults in Argentina | NCT07776249 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 21, 2026

Effect of the WAIO Digital Platform on Multidimensional Wellbeing in Adults in Argentina

Efecto sistémico de la Inteligencia Artificial en el Bienestar Integral en Argentina: un Modelo Multidimensional y Culturalmente Adaptado Basado en SAMHSA

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07776249
Lead Sponsor: Instituto Tecnológico de Buenos AiresOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 2,000Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jun 30, 2027Estimated
Completion Date: Jun 30, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Efecto sistémico de la Inteligencia Artificial en el Bienestar Integral en Argentina: un Modelo Multidimensional y Culturalmente Adaptado Basado en SAMHSA
Brief Summary: This study will evaluate the effect of an artificial intelligence-supported digital wellbeing platform, Wellbeing All-In-One (WAIO), on multidimensional wellbeing in adults living in Argentina.

The study includes an initial phase to evaluate and refine a culturally adapted wellbeing questionnaire based on the eight dimensions of the SAMHSA wellness framework. It will then conduct a randomized controlled trial in which participants are assigned to either immediate access to the WAIO platform or an active waitlist control group.

Participants will be followed for six months. The study will examine changes in self-reported wellbeing across physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental dimensions, as well as engagement, retention, and safety.

Conditions

The medical conditions and diseases this study investigates.

Wellbeing

Interventions

The treatments and procedures being evaluated in this study.

WAIO Multidimensional Digital Wellbeing Intervention
General Health Information Messages

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Inclusion Criteria:

Age 18 years or older.

Current residence in the Republic of Argentina, verified through an Argentine telephone prefix (+54).

Demonstrated functional digital competence, defined as the ability to independently complete the digital onboarding process, including QR code scanning, two-factor identity validation, and the baseline assessment.

Provision of digital informed consent.

Exclusion Criteria:

Age younger than 18 years.

Current residence outside the Republic of Argentina or inability to verify Argentine residence through the required telephone validation.

Inability to independently complete the required digital onboarding process.

Failure or refusal to provide digital informed consent.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Leonardo M Barral, MBAContact

lbarral@itba.edu.ar+5491167992205

Locations

Where the study is run and whether each site is currently recruiting.

Instituto Tecnológico de Buenos Aires (ITBA)

Buenos Aires, Buenos Aires F.D., Argentina

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Instituto Tecnológico de Buenos AiresOTHER

Similar Studies

Other registered studies that closely resemble this one.

This study uses a sequential mixed-method design consisting of an instrumental calibration phase followed by a two-arm, parallel randomized controlled trial.

During the initial instrumental phase, the preliminary 40-item WAIO Integral Wellbeing Inventory, culturally adapted from the SAMHSA eight-dimension wellness framework, will undergo psychometric evaluation. The first approximately 200 participants completing the baseline assessment will contribute to this phase. The planned evaluation includes assessment of internal consistency, factorial structure, convergent validity, comprehensibility, and test-retest reliability. Items retained after this prespecified calibration process will be used for subsequent longitudinal assessments.

The experimental phase will evaluate a digital wellbeing intervention delivered through the Wellbeing All-In-One (WAIO) progressive web application. WAIO integrates more than 30 interconnected digital tools organized around eight dimensions of wellbeing: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental. Artificial intelligence is used to personalize aspects of the user experience.

A total recruitment target of 2,000 adults in Argentina is planned. Participants entering the randomized phase will be allocated to one of two parallel groups. Participants in the immediate-intervention group will receive access to WAIO and weekly engagement messages. Participants in the active waitlist control group will receive general health information monthly and will not receive access to WAIO during the six-month comparison period. Access to WAIO will be provided to the waitlist group after completion of that period.

Participants will be assessed at baseline and followed longitudinally over six months. The study is designed to evaluate the trajectory of multidimensional wellbeing, the relationship between exposure to the digital intervention and changes in wellbeing, participant retention, and intervention safety.

The study includes prespecified safety procedures for the identification and management of potentially serious risk signals detected during use of the digital platform.