- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07782320
Generative AI-Based Health Education for Older Adults With Sarcopenic Obesity
20 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
500
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Hsin-Yen Yen, PhD
- Numéro de téléphone: 27749 886-2-2736-1661
- E-mail: kenji@tmu.edu.tw
Lieux d'étude
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Taipei, Taïwan, 110
- Taipei Medical University
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Contact:
- Hsin-Yen Yen, PhD
- Numéro de téléphone: 27749 886-2-2736-166
- E-mail: kenji@tmu.edu.tw
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Aucune intervention
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Comparateur actif: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Aucune intervention: Comparator Group
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Expérimental: Non-Personalized Gen-AI MHE
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Participants receive non-personalized multimodal health education generated by generative AI.
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Expérimental: Personalized Gen-AI MHE
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Participants receive personalized multimodal health education tailored through generative AI.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Chinese version of the Physical Activity Scale for the Elderly
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Health-Promoting Lifestyle Profile II
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
16 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- N202404120
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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