- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07782320
Generative AI-Based Health Education for Older Adults With Sarcopenic Obesity
20. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
500
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Hsin-Yen Yen, PhD
- Telefonnummer: 27749 886-2-2736-1661
- E-Mail: kenji@tmu.edu.tw
Studienorte
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Taipei, Taiwan, 110
- Taipei Medical University
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Kontakt:
- Hsin-Yen Yen, PhD
- Telefonnummer: 27749 886-2-2736-166
- E-Mail: kenji@tmu.edu.tw
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Kein Eingriff
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Aktiver Komparator: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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The Chinese version of the Physical Activity Scale for the Elderly
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The Health-Promoting Lifestyle Profile II
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2029
Studienabschluss (Geschätzt)
31. Dezember 2029
Studienanmeldedaten
Zuerst eingereicht
16. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. August 2026
Zuerst gepostet (Tatsächlich)
24. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. August 2026
Zuletzt verifiziert
1. Januar 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- N202404120
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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