- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07782320
Generative AI-Based Health Education for Older Adults With Sarcopenic Obesity
20 de agosto de 2026 actualizado por: Taipei Medical University
An Exploration of Health-Promoting Effects of Personalized AI-Generated Multimedia Health Education in Community-Dwelling Older Adults With Sarcopenic Obesity
Sarcopenic obesity is a major public health concern among community-dwelling older adult populations.Encouraging healthy behavior modification through health education emerges as an effective strategy for preventing and treating sarcopenic obesity.
Generative Artificial Intelligence (AI) offers an innovative opportunity to tailor health education for aging populations.
This study aims to explore the effectiveness of Personalized AI-generated Multimedia Health Education in community-dwelling older adults with sarcopenic obesity.
The study comprises two phases, with 280 participants in Study 1 and 180 in Study 2.Study 1, a cluster randomized controlled trial, explores the feasibility, acceptability, and efficacy of different AI-generated multimedia, including images, sounds, and videos.
Study 2 employs a three-armed,individually randomized controlled trial design, creating Personalized AI-generated Multimedia Health Education based on participant preferences.
All materials focus on behavioral risk factors, delivered by social media-based AI chatbots.
The intervention is conducted once a day, five days a week for 12 weeks.Structured questionnaires and objective instruments collect data before and after the intervention.
The study outcome includes behavioral and psychological factors, quality of life, and sarcopenic obesity indicators.
Statistical analyses include descriptive analyses, Chi-square tests, t-tests, One-way analysis of variance, path models, and generalized estimating equations.
This study anticipates that Personalized AI-generated Multimedia Health Education will be a feasible, acceptable, and effective intervention for older adults.
The study results are expected to demonstrate a significant improvement in study outcomes in the experimental group.
Personalized AI-generated multimedia health education could be an easy-to-use,enjoyable, and effective strategy for health promotion and sarcopenic obesity prevention.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
500
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hsin-Yen Yen, PhD
- Número de teléfono: 27749 886-2-2736-1661
- Correo electrónico: kenji@tmu.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán, 110
- Taipei Medical University
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Contacto:
- Hsin-Yen Yen, PhD
- Número de teléfono: 27749 886-2-2736-166
- Correo electrónico: kenji@tmu.edu.tw
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- . Age: 60 years or older
- . Smartphone ownership with internet connectivity
- . Appendicular fat-free mass (AFFM) calculated by the equation: AFFM = 14.529 + (17.989 * height)+ (0.1307 * fat mass). The cut-off value corresponds to a residual ≤ 3.4 in the equation
- . Ability to read, listen, and understand health education materials with normal cognitive function (MMSE score ≥ 25) and normal sensory function.
Exclusion Criteria:
- . Functional dependency
- . Current residence in long-term care facilities or hospitals
- . Presence of serious diagnosed diseases, disabilities, or mental health issues requiring medical treatment that might influence the study process.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Sin intervención
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Comparador activo: Generative Artificial Intelligence (AI)-based text materials
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Participants receive a text message regarding the health education topic.
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Experimental: Generative AI-based video materials
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Participants receive a video message , accompanied by AI-generated background music at the beginning and end.
Male avatars are used for PA and SO education, and female avatars are used for HD education.
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Experimental: Generative AI-based images materials
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Participants receive one Gen-AI-generated image concerning the health education topic, formatted as a health poster.
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Experimental: Generative AI-based voice materials
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Participants receive a podcast-style voice message regarding the health education topic.
The recording incorporates AI-generated background voice.
Male voices are utilized for physical activity (PA) education, while female voices are used for healthy diet (HD) and sarcopenic obesity (SO) education.
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Sin intervención: Comparator Group
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Experimental: Non-Personalized Gen-AI MHE
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Participants receive non-personalized multimodal health education generated by generative AI.
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Experimental: Personalized Gen-AI MHE
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Participants receive personalized multimodal health education tailored through generative AI.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Chinese version of the Physical Activity Scale for the Elderly
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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This questionnaire consists of 12 items assessing physical activity (PA) over the past 7 days, including leisure-time, household, and occupational activities.
Total, light-, moderate-, and vigorous-intensity PA can be calculated in metabolic equivalents of task-minutes per week (MET-min/week).
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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General Dietary Behavior Inventory
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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A total of 16 items measure participants' healthy behaviors using a 5-point bipolar scale.The score of each item is summed up to a total score, with a higher score representing healthier dietary behavior.
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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The skeletal muscle index (SMI)
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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A body composition analyzer using bioelectrical impedance analysis technology is conducted.
A higher score (kg/m2) of the skeletal muscle index (SMI) indicates greater muscle mass for sarcopenic indicators.
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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Muscle Strength
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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Muscle strength is assessed using a handheld grip device (SANKA, Japan).
Participants are asked to stand, allow the wrist and arm of the dominant hand to hang straight down, and maintain maximum strength for more than 3 seconds.
This measurement is repeated three times, and the maximum value (kg) is used as the muscle strength.
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Health-Promoting Lifestyle Profile II
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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The Health-Promoting Lifestyle Profile II consists of 29 items measuring participants' engagement in healthy lifestyles.
A 4-point Likert scale is used (1 never, 2 sometimes, 3 frequently, and 4 regularly).
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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World Health Organization (WHO)- Quality of Life Scale
Periodo de tiempo: Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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A shorter version with 28 questions.
The scale evaluates various aspects of life, including physical health, psychological state, social relationships, and environmental factors, scored between 1 and 5.
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Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
16 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- N202404120
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .