Effect of the WAIO Digital Platform on Multidimensional Wellbeing in Adults in Argentina
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Leonardo M Barral, MBA
- Номер телефона: +5491167992205
- Электронная почта: lbarral@itba.edu.ar
Места учебы
-
-
Buenos Aires F.D.
-
Buenos Aires, Buenos Aires F.D., Аргентина
- Instituto Tecnológico de Buenos Aires (ITBA)
-
Контакт:
- Leonardo M Barral, MBA
- Номер телефона: +5491167992205
- Электронная почта: lbarral@itba.edu.ar
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
|
|
Активный компаратор: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Internal Consistency of the WAIO Integral Wellbeing Inventory
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Leonardo M Barral, MBA, Instituto Tecnológico de Buenos Aires
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- ITBA-WAIO-RCT-001
- 17771 (Другой идентификатор: Ministerio de Salud, Gobierno de la Ciudad Autónoma de Buenos Aires (PRIISA.BA))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .