NCT07782320

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

August 24, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

August 16, 2026

Last Update Submit

August 20, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Chinese version of the Physical Activity Scale for the Elderly

    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).

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

  • General Dietary Behavior Inventory

    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.

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

  • The skeletal muscle index (SMI)

    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.

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

  • Muscle Strength

    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.

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

Secondary Outcomes (2)

  • The Health-Promoting Lifestyle Profile II

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

  • World Health Organization (WHO)- Quality of Life Scale

    Baseline, midpoint (the 6th week), and post-intervention (the 13rd week)

Study Arms (8)

No Intervention

NO INTERVENTION

Generative Artificial Intelligence (AI)-based text materials

ACTIVE COMPARATOR
Behavioral: Generative AI-based text materials

Generative AI-based video materials

EXPERIMENTAL
Behavioral: Generative AI-based video materials

Generative AI-based images materials

EXPERIMENTAL
Behavioral: Generative AI-based images materials

Generative AI-based voice materials

EXPERIMENTAL
Behavioral: Generative AI-based voice materials

Comparator Group

NO INTERVENTION

Non-Personalized Gen-AI MHE

EXPERIMENTAL
Behavioral: Non-Personalized Gen-AI MHE

Personalized Gen-AI MHE

EXPERIMENTAL
Behavioral: Personalized Gen-AI MHE

Interventions

Participants receive a text message regarding the health education topic.

Generative Artificial Intelligence (AI)-based text materials

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.

Generative AI-based video materials

Participants receive one Gen-AI-generated image concerning the health education topic, formatted as a health poster.

Generative AI-based images materials

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.

Generative AI-based voice materials

Participants receive non-personalized multimodal health education generated by generative AI.

Non-Personalized Gen-AI MHE

Participants receive personalized multimodal health education tailored through generative AI.

Personalized Gen-AI MHE

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Central Study Contacts

Hsin-Yen Yen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 24, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

August 24, 2026

Record last verified: 2026-01

Locations