- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 110
- Taipei Medical University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Usual Care Control Group
Participants receive usual care and do not participate in the structured intervention program.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sarcopenia literacy quscitonaire
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 113TMUHP0
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Livsstil
-
Rambam Health Care CampusUkendtat sammenligne LIF-niveau i navlestrengsblod fra embryoer, der er IUGR, med dem, der er AGA
Kliniske forsøg med Multicomponent Intervention
-
Hacettepe UniversityTilmelding efter invitationEfterår | Erkendelse | Ergoterapi | Geriatrisk | BalanceTyrkiet (Türkiye)
-
Neslihan LokSelcuk UniversityAfsluttetÆldre voksneTyrkiet (Türkiye)
-
China Medical University HospitalAfsluttetSkrøbelighed | Aldring | Fysisk inaktivitetTaiwan
-
University of TennesseeAfsluttetDiabetes | Diabetes type 2 | Overvægt, FedmeForenede Stater
-
Brown UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereAfsluttetKost, sundForenede Stater
-
Guangxi Medical UniversityIkke rekrutterer endnu
-
Fundacion Miguel ServetRekrutteringBrystkræft | Skrøbelighed | Sarkopeni | Aldring | Funktionelt faldSpanien
-
Universidad de BurgosHospital Universitario de BurgosIkke rekrutterer endnuTransthyretin hjerteamyloidose
-
City University of New York, School of Public HealthHanoi University of Public HealthAfsluttet
-
Biolux Research Holdings, Inc.AfsluttetOrtodontisk tandbevægelseCanada