- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07782320
Generative AI-Based Health Education for Older Adults With Sarcopenic Obesity
20. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hsin-Yen Yen, PhD
- Telefonnummer: 27749 886-2-2736-1661
- E-post: kenji@tmu.edu.tw
Studiesteder
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Taipei, Taiwan, 110
- Taipei Medical University
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Ta kontakt med:
- Hsin-Yen Yen, PhD
- Telefonnummer: 27749 886-2-2736-166
- E-post: kenji@tmu.edu.tw
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Ingen inngrep
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Aktiv 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Ingen inngripen: Comparator Group
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Eksperimentell: Non-Personalized Gen-AI MHE
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Participants receive non-personalized multimodal health education generated by generative AI.
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Eksperimentell: Personalized Gen-AI MHE
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Participants receive personalized multimodal health education tailored through generative AI.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Chinese version of the Physical Activity Scale for the Elderly
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Health-Promoting Lifestyle Profile II
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
31. desember 2029
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
16. august 2026
Først innsendt som oppfylte QC-kriteriene
20. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. januar 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- N202404120
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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