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

2026年8月19日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

2000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Buenos Aires F.D.
      • Buenos Aires、Buenos Aires F.D.、阿根廷
        • Instituto Tecnológico de Buenos Aires (ITBA)
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Internal Consistency of the WAIO Integral Wellbeing Inventory
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Leonardo M Barral, MBA、Instituto Tecnológico de Buenos Aires

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年8月17日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • ITBA-WAIO-RCT-001
  • 17771 (其他标识符:Ministerio de Salud, Gobierno de la Ciudad Autónoma de Buenos Aires (PRIISA.BA))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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