- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 110
- Taipei Medical University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Kein Eingriff: Usual Care Control Group
Participants receive usual care and do not participate in the structured intervention program.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sarcopenia literacy quscitonaire
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 113TMUHP0
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lebensstil
-
Rambam Health Care CampusUnbekanntLIF-STUFEN IN NABELBLUT UND MÜTTERLICHEM BLUT WÄHREND DER WEITE
-
Rambam Health Care CampusUnbekanntVergleich des LIF-Spiegels im Nabelschnurblut von Embryonen, die IUGR sind, mit denen, die AGA sind
Klinische Studien zur Multicomponent Intervention
-
Neslihan LokSelcuk UniversityAbgeschlossenÄltere ErwachseneTürkei (türkiye)
-
Gdansk University of Physical Education and SportUniversity of CadizNoch keine Rekrutierung
-
Brown UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... und andere MitarbeiterAbgeschlossenDiät, gesundVereinigte Staaten
-
University of FloridaAbgeschlossenEmpfindlichkeitVereinigte Staaten
-
Universidad de ExtremaduraDiputación Provincial de BadajozRekrutierungGesundheitserziehung | Gamification in der GesundheitserziehungSpanien
-
Faculdade de Motricidade HumanaFundação para a Ciência e a Tecnologia (FCT)Noch keine Rekrutierung
-
University of WashingtonNational Cancer Institute (NCI)AbgeschlossenMelanom | Lymphom | Gebärmutterhalskrebs | Leukämie | Brustkrebs | Darmkrebs | Darmkrebs | Bösartige NeubildungVereinigte Staaten
-
Rabin Medical CenterAcademic College of Tel Aviv-Jaffa; Israel Cancer AssociationUnbekanntEierstockkrebs | Krebs des Gebärmutterhalses | Krebs des EndometriumsIsrael
-
Case Western Reserve UniversityAktiv, nicht rekrutierend
-
Cairo UniversityNoch keine RekrutierungGenauigkeit verschiedener Scantechniken