Health LiteracyNCT07654478
Health Literacy-Based Multifactorial Program for Adults With Sarcopenia
A study testing Multicomponent Intervention in people with Health Literacy and Middle Aged, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Middle Aged, Elderly (People Aged 65 or More)
- What is being tested?
- Multicomponent Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2024to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 40 years old (2) has willingness to participate our multifactorial approach. (3) Participants eligible for intervention following assessment by a rehabilitation physician
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Health Literacy-Based Multifactorial Intervention for Middle-Aged and Older 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.
Read the detailed description
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.
- Conditions
- Health Literacy, Middle Aged, Elderly (People Aged 65 or More), Exercise Therapy, Life Style
- Being tested
- Multicomponent Intervention
- Keywords
- sarcopenia, exercise, nutrition, education, multifactorial approach, health literathy
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Intervention Group | Experimental | Participants in the intervention group will receive a structured multicomponent program designed to improve sarcopenia-related health literacy and promote healthy lifestyle behaviors. The program consists of six 60-minute sessions delivered over the intervention period.
Each session includes health education focusing on sarcopenia awareness, risk factors, prevention strategies, and self-management, combined with supervised exercise training. The exercise component is designed to improve physical function and promote regular physical activity. Participants will receive guidance aimed at enhancing understanding and application of health information in daily life. Receives: Behavioral: Multicomponent Intervention |
| Usual Care Control Group | No intervention | Participants receive usual care and do not participate in the structured intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia literacy quscitonaire
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.
Measured: Baseline, immediately post-intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start4 Dec 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654478
- Sponsor's protocol ID
- 113TMUHP0
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns and because data sharing was not included in the informed consent obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Health Literacy-Based Multifactorial Intervention for Middle-Aged and Older Adults With Sarcopenia
- ClinicalTrials.gov ID
- NCT07654478
- Acronym / sponsor ID
- 113TMUHP0
- Conditions
- Health Literacy, Middle Aged, Elderly (People Aged 65 or More), Exercise Therapy, Life Style
- Keywords
- sarcopenia, exercise, nutrition, education, multifactorial approach, health literathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Intervention Group | Experimental | Behavioral: Multicomponent InterventionParticipants in the intervention group will receive a structured multicomponent program designed to improve sarcopenia-related health literacy and promote healthy lifestyle behaviors. The program consists of six 60-minute sessions delivered over the intervention period. Each session includes health education focusing on sarcopenia awareness, risk factors, prevention strategies, and self-management, combined with supervised exercise training. The exercise component is designed to improve physical function and promote regular physical activity. Participants will receive guidance aimed at enhancing understanding and application of health information in daily life. |
| Usual Care Control Group | No intervention | –Participants receive usual care and do not participate in the structured intervention program. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Age ≥ 40 years old (2) has willingness to participate our multifactorial approach. (3) Participants eligible for intervention following assessment by a rehabilitation physician
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent InterventionA 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. | Behavioural | Multicomponent Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns and because data sharing was not included in the informed consent obtained from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Intervention in people with Health Literacy and Middle Aged, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia literacy quscitonaire (time frame: Baseline, immediately post-intervention, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.