WellbeingNCT07776249
Effect of the WAIO Digital Platform on Multidimensional Wellbeing in Adults in Argentina
A study testing WAIO Multidimensional Digital Wellbeing Intervention and General Health Information Messages in people with Wellbeing, run by Instituto Tecnológico de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wellbeing
- What is being tested?
- WAIO Multidimensional Digital Wellbeing Intervention and General Health Information Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site
Instituto Tecnológico de Buenos Aires (ITBA)
Buenos Aires, Buenos Aires F.D.
Leonardo M Barral, MBA, +5491167992205, lbarral@itba.edu.ar
About this study
Official title: Efecto sistémico de la Inteligencia Artificial en el Bienestar Integral en Argentina: un Modelo Multidimensional y Culturalmente Adaptado Basado en SAMHSA
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.
Read the detailed description
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.
- Conditions
- Wellbeing
- Being tested
- WAIO Multidimensional Digital Wellbeing Intervention, General Health Information Messages
- Keywords
- Artificial Intelligence, Digital Health, Multidimensional Wellbeing, SAMHSA Eight Dimensions of Wellness, Mobile Health, Randomized Controlled Trial, Argentina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAIO Multidimensional Digital Wellbeing InterventionBehavioural
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 MessagesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General Health Information Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (6)
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.
Measured: Baseline and 3 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: 3 months and 6 months
Incidence of Adverse Events and Serious Adverse Events
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.
Measured: From baseline through 6 months
Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing
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.
Measured: From baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnológico de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Martin Barral, Instituto Tecnológico de Buenos Aires
- Investigators
- Leonardo M Barral, MBA, Principal investigator, Instituto Tecnológico de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776249
- Sponsor's protocol ID
- ITBA-WAIO-RCT-001
- Other IDs
- 17771
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study results will be reported in aggregate form. Participant data will be anonymized and protected in accordance with the approved study protocol and applicable data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efecto sistémico de la Inteligencia Artificial en el Bienestar Integral en Argentina: un Modelo Multidimensional y Culturalmente Adaptado Basado en SAMHSA
- ClinicalTrials.gov ID
- NCT07776249
- Acronym / sponsor ID
- ITBA-WAIO-RCT-001
- Conditions
- Wellbeing
- Keywords
- Artificial Intelligence, Digital Health, Multidimensional Wellbeing, SAMHSA Eight Dimensions of Wellness, Mobile Health, Randomized Controlled Trial, Argentina
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Instituto Tecnológico de Buenos AiresUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate WAIO Access | Experimental | Behavioral: WAIO Multidimensional Digital Wellbeing InterventionParticipants 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. |
| Active Waitlist Control | Active comparator | Behavioral: General Health Information MessagesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAIO Multidimensional Digital Wellbeing InterventionA 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. | Behavioural | Immediate WAIO Access |
| General Health Information MessagesParticipants 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. | Behavioural | Active Waitlist Control |
Primary outcome
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.
6 secondary outcomes
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months
Time frame: Baseline and 3 months
Change in the Eight Dimension-Specific WAIO Wellbeing Scores
Time frame: Baseline, 3 months, and 6 months
Change in Self-Rated General Health
Time frame: Baseline, 3 months, and 6 months
Participant Retention Rate at 3 and 6 Months
Time frame: 3 months and 6 months
Incidence of Adverse Events and Serious Adverse Events
Time frame: From baseline through 6 months
Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing
Time frame: From baseline through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study results will be reported in aggregate form. Participant data will be anonymized and protected in accordance with the approved study protocol and applicable data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo M Barral, MBA principal investigator
Instituto Tecnológico de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAIO Multidimensional Digital Wellbeing Intervention and General Health Information Messages in people with Wellbeing, run by Instituto Tecnológico de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonardo M Barral, MBA (+5491167992205, lbarral@itba.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.