Wellbeing
Conditions
Keywords
Artificial Intelligence, Digital Health, Multidimensional Wellbeing, SAMHSA Eight Dimensions of Wellness, Mobile Health, Randomized Controlled Trial, Argentina
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.
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.
Interventions
BEHAVIORALWAIO 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.
BEHAVIORALGeneral 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.
Sponsors
Instituto Tecnológico de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months | 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. |
| Change in the Eight Dimension-Specific WAIO Wellbeing Scores | 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. |
| Change in Self-Rated General Health | 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. |
| Participant Retention Rate at 3 and 6 Months | 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. |
| Incidence of Adverse Events and Serious Adverse Events | 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. |
| Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing | 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. |
Countries
Argentina
Contacts
CONTACTLeonardo M Barral, MBA
PRINCIPAL_INVESTIGATORLeonardo M Barral, MBA
Instituto Tecnológico de Buenos Aires
Outcome results
None listed