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Completed

NCT Number: NCT07654478

Health Literacy-Based Multifactorial Program for Adults With Sarcopenia

Sarcopenia is a common age-related condition characterized by the progressive loss of muscle mass and function, which may lead to reduced physical performance, disability, and poorer quality of life. Exercise and nutritional management are considered the primary interventions for preventing and managing sarcopenia; however, successful implementation requires long-term lifestyle modifications. Previous studies have indicated that health literacy among the general population in Taiwan remains insufficient, potentially limiting individuals' ability to adopt and maintain healthy behaviors. Therefore, interventions that improve health literacy may help promote healthy aging and sarcopenia prevention.

The purpose of this study is to develop a sarcopenia-specific health literacy questionnaire and to evaluate the effectiveness of a health literacy-based multifactorial intervention among community-dwelling middle-aged and older adults. A total of 100 participants will be enrolled and assigned to either an intervention group (n=50) or a control group (n=50). The intervention group will participate in six 60-minute sessions consisting of health education and exercise training. Health literacy and other self-reported outcomes will be assessed before and after the intervention, with follow-up assessments conducted three months later. The study aims to determine whether the intervention can improve participants' health literacy and support the adoption of healthy lifestyle behaviors related to sarcopenia prevention and management.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Taipei City, 110, Taiwan

About this study

This study is a nonrandomized controlled trial designed to evaluate the effects of a health literacy-based multifactorial intervention in middle-aged and older adults with sarcopenia. Participants will be recruited from outpatient rehabilitation referrals at Taipei Medical University Hospital and from the community. A total of 100 participants will be enrolled and assigned to either an intervention group (n=50) or a control group (n=50).

Eligible participants are adults aged 40 years or older who are willing to participate in a multifactorial intervention program. Participants will be excluded if they are unable to complete six intervention sessions and follow-up assessments over a 3-month period, have cognitive impairments that prevent them from understanding or completing questionnaires, or have medical conditions that contraindicate participation in physical activity.

The intervention consists of six 60-minute sessions delivered over the study period. Each session includes structured health education and exercise training aimed at improving health literacy, enhancing awareness of sarcopenia, and promoting healthy lifestyle behaviors. The control group will receive usual care without structured intervention.

Outcomes will be assessed at baseline, immediately post-intervention, and at 3-month follow-up. The primary outcome is health literacy, measured using a sarcopenia-specific health literacy questionnaire developed in this study. Secondary outcomes may include self-reported health behaviors and related functional indicators.

Data will be analyzed using SPSS version 22.0. Descriptive statistics will be used to summarize participant characteristics. Independent t-tests and/or repeated measures analyses will be used to compare changes between groups. A p-value of less than 0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Age ≥ 40 years old (2) has willingness to participate our multifactorial approach. (3) Participants eligible for intervention following assessment by a rehabilitation physician

Exclusion criteria

  • (1) unable to complete all the sic sections of multifactorial approach and lost follow up. (2) unable to comprehend and finish the sarcopenia literacy questionnaire, or has other conditions that could not participation the activities. (3)Participants with other medical conditions that could not participate the intervention will be excluded.

Treatment and study plan

multicomponent intervention

Behavioral

A structured intervention consisting of six 60-minute sessions that combine health education and exercise training. The program is designed to improve sarcopenia-related health literacy, increase awareness of sarcopenia prevention, and promote healthy lifestyle behaviors among middle-aged and older adults.

Primary outcomes

  1. Sarcopenia literacy quscitonaire

    Time frame: Baseline, immediately post-intervention, and 3-month follow-up

    Sarcopenia-related health literacy will be assessed using a sarcopenia-specific health literacy questionnaire developed in this study. The questionnaire evaluates participants' knowledge, understanding, and ability to apply health information related to sarcopenia prevention and management. Higher scores indicate better health literacy.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

The Effects of a Health Literacy-Based Multifactorial Intervention for Middle-Aged and Older Adults With Sarcopenia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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