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

NCT07776249 | Not Yet Recruiting

• 2 other identifiers: ITBA-WAIO-RCT-00117771
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Wellbeing

Keywords

Artificial Intelligence; Digital Health; Multidimensional Wellbeing; SAMHSA Eight Dimensions of Wellness; Mobile Health; Randomized Controlled Trial; Argentina

Outcome Measures

Primary Outcomes (1)

• Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months

  The WAIO Integral Wellbeing Inventory assesses self-reported wellbeing across eight dimensions based on the SAMHSA wellness framework: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental wellbeing. A standardized overall score ranging from 0 to 100 will be calculated, with higher scores indicating higher integral wellbeing. Longitudinal scoring will use the items retained after the prespecified psychometric calibration phase.

  Baseline and 6 months

Secondary Outcomes (6)

• Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months

  Baseline and 3 months

• Change in the Eight Dimension-Specific WAIO Wellbeing Scores

  Baseline, 3 months, and 6 months

• Change in Self-Rated General Health

  Baseline, 3 months, and 6 months

• Participant Retention Rate at 3 and 6 Months

  3 months and 6 months

• Incidence of Adverse Events and Serious Adverse Events

  From baseline through 6 months

Other Outcomes (4)

• Internal Consistency of the WAIO Integral Wellbeing Inventory

  Baseline

• Factorial Structure of the WAIO Integral Wellbeing Inventory

  Baseline

• Convergent Validity of the WAIO Integral Wellbeing Inventory

  Baseline

Study Arms (2)

Immediate WAIO Access

EXPERIMENTAL

Participants assigned to this arm will receive immediate access to the Wellbeing All-In-One (WAIO) progressive web application for the 6-month study period. They will also receive one weekly WhatsApp message encouraging engagement with the platform. WAIO integrates more than 30 interconnected digital tools organized across eight dimensions of wellbeing: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental.

Behavioral: WAIO Multidimensional Digital Wellbeing Intervention

Active Waitlist Control

ACTIVE COMPARATOR

Participants assigned to this arm will not receive access to the WAIO platform during the 6-month comparison period. They will receive one general health information message per month through WhatsApp. After completion of the 6-month comparison period, participants will be offered access to WAIO beginning in month 7.

Behavioral: General Health Information Messages

Interventions

WAIO Multidimensional Digital Wellbeing Intervention BEHAVIORAL

A digital wellbeing intervention delivered through the Wellbeing All-In-One (WAIO) progressive web application. The platform integrates more than 30 interconnected digital tools organized across eight dimensions of wellbeing: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental. Artificial intelligence is used to personalize aspects of the user experience. Participants assigned to the immediate-intervention arm receive access to the platform during the 6-month comparison period and one weekly WhatsApp message encouraging engagement.

Immediate WAIO Access

General Health Information Messages BEHAVIORAL

Participants assigned to the active waitlist control arm receive one general health information message per month through WhatsApp during the 6-month comparison period. They do not receive access to the WAIO platform during this period. Access to WAIO is offered after completion of the 6-month comparison period, beginning in month 7.

Active Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Tecnológico de Buenos Aires: lead

Study Sites (1)

Instituto Tecnológico de Buenos Aires (ITBA)

Buenos Aires, Buenos Aires F.D., Argentina

Location

Study Officials

• Leonardo M Barral, MBA

  Instituto Tecnológico de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo M Barral, MBA

CONTACT

+5491167992205; lbarral@itba.edu.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student in Systemic Innovation Management

Model Details: The study includes an initial psychometric calibration phase followed by a two-arm parallel randomized controlled trial comparing immediate access to the WAIO digital intervention with an active waitlist control.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)