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NCT Number: NCT07776249

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

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.

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Key information

Conditions

Wellbeing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Tecnológico de Buenos Aires (ITBA)

Buenos Aires, Buenos Aires F.D., Argentina

Location contact

Leonardo M Barral, MBA

CONTACT

[email protected]

+5491167992205

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and 3 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.

  2. Change in the Eight Dimension-Specific WAIO Wellbeing Scores

    Time frame: Baseline, 3 months, and 6 months

    Dimension-specific wellbeing scores will be calculated for the eight domains assessed by the WAIO Integral Wellbeing Inventory: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental wellbeing. Each dimension-specific score will be standardized on a 0-to-100 scale, with higher scores indicating higher wellbeing in that dimension. Scores will be derived from the items retained after the prespecified psychometric calibration phase. Changes over time will be evaluated separately for each wellbeing dimension.

  3. Change in Self-Rated General Health

    Time frame: Baseline, 3 months, and 6 months

    Self-rated general health will be assessed using a single-item measure asking participants to rate their health in general. Response categories are Excellent, Very Good, Good, Fair, and Poor. Changes in the distribution of self-rated health responses will be evaluated over the follow-up period.

  4. Participant Retention Rate at 3 and 6 Months

    Time frame: 3 months and 6 months

    Percentage of randomized participants who remain in the study at each scheduled follow-up time point. Retention will be assessed at T1 (3 months) and T2 (6 months) using study and platform records.

  5. Incidence of Adverse Events and Serious Adverse Events

    Time frame: From baseline through 6 months

    The number and proportion of participants experiencing one or more adverse events or serious adverse events during the 6-month follow-up period will be assessed. Safety events will be identified through the study's SOS reporting mechanism and active safety monitoring procedures.

  6. Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing

    Time frame: From baseline through 6 months

    Among participants assigned to the immediate WAIO intervention arm, exposure to the digital intervention will be quantified using backend logs, including total time of use, frequency of accesses, and completion rate. Correlation analyses will assess the relationship between these exposure indicators and the magnitude of change in overall and dimension-specific wellbeing scores from baseline to 6 months.

Other outcomes

  1. Internal Consistency of the WAIO Integral Wellbeing Inventory

    Time frame: Baseline

    Internal consistency of the preliminary WAIO Integral Wellbeing Inventory and its dimension-specific subscales will be evaluated using Cronbach's alpha and McDonald's omega during the psychometric calibration phase. The protocol prespecifies a Cronbach's alpha threshold of 0.70 or higher for acceptable internal consistency of each subscale.

  2. Factorial Structure of the WAIO Integral Wellbeing Inventory

    Time frame: Baseline

    The factorial structure of the preliminary 40-item WAIO Integral Wellbeing Inventory will be evaluated using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to assess support for the hypothesized eight-dimensional wellbeing structure based on the SAMHSA framework.

  3. Convergent Validity of the WAIO Integral Wellbeing Inventory

    Time frame: Baseline

    Convergent validity of the WAIO Integral Wellbeing Inventory will be evaluated by examining correlations between WAIO wellbeing scores and standardized measures assessing related constructs during the psychometric calibration phase.

  4. Test-Retest Reliability of the WAIO Integral Wellbeing Inventory

    Time frame: Baseline and 14 days

    Temporal stability of the WAIO Integral Wellbeing Inventory will be assessed in a randomly selected 10% subsample of participants from the psychometric calibration phase (approximately 20 participants). The inventory will be administered again 14 days after the baseline assessment, during an intervention-free interval. Test-retest reliability will be evaluated using the intraclass correlation coefficient (ICC), with ICC greater than 0.75 prespecified as the threshold for acceptable temporal stability.

Study contacts

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

Leonardo M Barral, MBA

CONTACT

[email protected]

+5491167992205

Sponsors and collaborators

Lead sponsor

Instituto Tecnológico de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 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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