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

2026. augusztus 19. frissítette: Leonardo Martin Barral, Instituto Tecnológico de Buenos Aires

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

2000

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Argentína
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentína
        • Instituto Tecnológico de Buenos Aires (ITBA)
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Igen

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egyéb
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Immediate WAIO Access
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.
Viselkedési: WAIO Multidimensional Digital Wellbeing Intervention
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.
Aktív összehasonlító: Active Waitlist Control
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.
Viselkedési: General Health Information Messages
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months
Időkeret: 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.
Baseline and 6 months

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months
Időkeret: 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.
Baseline and 3 months
Change in the Eight Dimension-Specific WAIO Wellbeing Scores
Időkeret: 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.
Baseline, 3 months, and 6 months
Change in Self-Rated General Health
Időkeret: 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.
Baseline, 3 months, and 6 months
Participant Retention Rate at 3 and 6 Months
Időkeret: 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.
3 months and 6 months
Incidence of Adverse Events and Serious Adverse Events
Időkeret: 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.
From baseline through 6 months
Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing
Időkeret: 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.
From baseline through 6 months

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Internal Consistency of the WAIO Integral Wellbeing Inventory
Időkeret: Baseline

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.
Baseline
Factorial Structure of the WAIO Integral Wellbeing Inventory
Időkeret: Baseline

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.
Baseline
Convergent Validity of the WAIO Integral Wellbeing Inventory
Időkeret: Baseline

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.
Baseline
Test-Retest Reliability of the WAIO Integral Wellbeing Inventory
Időkeret: Baseline and 14 days

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.
Baseline and 14 days

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Instituto Tecnológico de Buenos Aires

Nyomozók

  • Kutatásvezető: Leonardo M Barral, MBA, Instituto Tecnológico de Buenos Aires

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. október 1.

Elsődleges befejezés (Becsült)

2027. június 30.

A tanulmány befejezése (Becsült)

2027. június 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 17.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 17.

Első közzététel (Tényleges)

2026. augusztus 20.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 21.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 19.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • ITBA-WAIO-RCT-001
  • 17771 (Egyéb azonosító: Ministerio de Salud, Gobierno de la Ciudad Autónoma de Buenos Aires (PRIISA.BA))

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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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