- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654478
Health Literacy-Based Multifactorial Program for Adults With Sarcopenia
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 110
- Taipei Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multicomponent Intervention Group
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. |
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.
|
|
No Intervention: Usual Care Control Group
Participants receive usual care and do not participate in the structured intervention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113TMUHP0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Life Style
-
VASCage GmbHMedical University Innsbruck; Tirol Kiniken GmbH; Management Center InnsbruckCompletedLife Style, Healthy | Life StyleAustria
-
Universidad de ExtremaduraActive, not recruitingLife Style, Healthy | Life Style Modification | Life Quality | Physical ActivitiesSpain
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Colorado School of Public HealthNational Institute for Occupational Safety and Health (NIOSH/CDC)Completed
-
Clalit Health ServicesCompleted
-
Royal College of Surgeons, IrelandNot yet recruitingLife Style, Healthy | PopulationIreland
-
M.D. Anderson Cancer CenterActive, not recruitingHealthy Lifestyle | Life StyleUnited States
-
Dawn BrewerCompletedDiet, Healthy | Life Style, HealthyUnited States
-
National Health Service, United KingdomCompletedAging | Dietary Habits | Life StyleUnited Kingdom
Clinical Trials on Multicomponent Intervention
-
Hospital Universitario GetafeKarolinska Institutet; Medical University of Lodz; Universidad Politecnica de... and other collaboratorsUnknownFrail Elderly Syndrome | Frailty | Frailty SyndromePoland, Spain, Sweden
-
University Rovira i VirgiliDiputació de TarragonaCompletedDiet Modification | Food Preferences | Diet Habit | Food Allergy | Food Intolerance | InterventionSpain
-
University of PittsburghHealth Resources and Services Administration (HRSA)Completed
-
Aga Khan UniversityUniversity of YorkActive, not recruitingHypertensionPakistan
-
Duke-NUS Graduate Medical SchoolCompleted
-
Servicio Canario de SaludInstituto de Salud Carlos IIICompletedSystemic Lupus ErythematosusSpain
-
Universidad Antonio NariñoEnrolling by invitationFluorosis | Fluorosis, DentalColombia
-
Universidad Antonio NariñoActive, not recruitingFluorosis | Fluorosis, DentalColombia
-
Duke-NUS Graduate Medical SchoolNational University Polyclinics, Singapore; SingHealth PolyclinicsActive, not recruitingChronic Kidney DiseasesSingapore
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative... and other collaboratorsCompletedKidney Diseases | End Stage Renal Disease | Kidney FailureCanada