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

ConditionWellbeing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Tecnológico de Buenos Aires

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Immediate WAIO AccessExperimental treatment 1 intervention
Group B: Active Waitlist ControlActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 6 months

Secondary outcomes

1

Change in WAIO Integral Wellbeing Standardized Score From Baseline to 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.

Time frame
Baseline and 3 months
2

Change in the Eight Dimension-Specific WAIO Wellbeing Scores

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.

Time frame
Baseline, 3 months, and 6 months
3

Change in Self-Rated General Health

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.

Time frame
Baseline, 3 months, and 6 months
4

Participant Retention Rate at 3 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.

Time frame
3 months and 6 months

Other outcomes

1

Internal Consistency of the WAIO Integral Wellbeing Inventory

The scale used is the Wellbeing All-In-One (WAIO) Integral Wellbeing Inventory. Its standardized wellbeing scores range from 0 to 100, with higher scores indicating higher wellbeing. 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. A Cronbach's alpha of 0.70 or higher is prespecified as the threshold for acceptable internal consistency of each subscale.

Time frame
Baseline
2

Factorial Structure of the WAIO Integral Wellbeing Inventory

The scale used is the Wellbeing All-In-One (WAIO) Integral Wellbeing Inventory. Standardized wellbeing scores derived from the inventory range from 0 to 100, with higher scores indicating higher wellbeing. 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.

Time frame
Baseline
3

Convergent Validity of the WAIO Integral Wellbeing Inventory

The scale used is the Wellbeing All-In-One (WAIO) Integral Wellbeing Inventory. Its standardized wellbeing score ranges from 0 to 100, with higher scores indicating higher wellbeing. Convergent validity will be evaluated by examining correlations between WAIO Integral Wellbeing Inventory scores and standardized measures assessing related constructs during the psychometric calibration phase. The outcome of this analysis will be the strength and direction of the correlations between these measures.

Time frame
Baseline
4

Test-Retest Reliability of the WAIO Integral Wellbeing Inventory

The scale used is the Wellbeing All-In-One (WAIO) Integral Wellbeing Inventory. Its standardized wellbeing score ranges from 0 to 100, with higher scores indicating higher wellbeing. 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 higher ICC values indicating greater temporal stability. An ICC greater than 0.75 is prespecified as the threshold for acceptable temporal stability.

Time frame
Baseline and 14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: