- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07504419
A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking
A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking: A Comparative Analysis of Community Practices in Taiwan and Japan
Study Overview
Status
Intervention / Treatment
Detailed Description
This project will first conduct a preliminary health screening using the "Integrated Elderly Care Screening Scale" to understand the physical function status of the subjects. If the screening results show that the group is at high risk of frailty, a one-on-one interview will be arranged to further understand their nutrition-related issues and needs. Through the compilation of interview data, a product or service process for nutrition education will be designed and incorporated into subsequent nutrition care.
Participants will fill out questionnaires before and after nutrition education intervention to evaluate physiological functions and health behaviors. The physiological function assessment includes four aspects: chewing function, swallowing function, nutritional status and frailty. This procedure aims to understand the potential improvement effect of this care model on the physiological functions and daily health behaviors of the elderly, and compare it with the results of Settsu City, Osaka, Japan.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wanhua District
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New Taipei City, Wanhua District, Taiwan, 10860
- Dingshuo Village Residential Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elderly people aged 65 and above with nutrition-related risks were screened by the ICOPE (Integrated Care for Older People) scale, that is, those with abnormalities in cognition, mobility, malnutrition, depression, etc., and were defined as high-risk elderly people.
Exclusion Criteria:
- Those who cannot eat independently, such as those who rely on nasogastric tubes for feeding.
- Those who cannot express their opinions independently.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nutrition education
|
Nutrition education course design will be based on interview results with subjects with high risk of frailty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chewing function
Time Frame: Baseline and 2 months after intervention
|
Chewing function will be assessed using a chewing status question adapted from the Japanese National Health and Nutrition Survey.
Higher scores indicate better chewing ability.
|
Baseline and 2 months after intervention
|
|
Eating Assessment Tool-10 (EAT-10)
Time Frame: Baseline and 2 months after intervention
|
The Eating Assessment Tool-10 (EAT-10) is a self-administered questionnaire ranging from 0 to 40, with higher scores indicating more severe swallowing difficulties.
|
Baseline and 2 months after intervention
|
|
Mini Nutritional Assessment-Short Form (MNA-SF)
Time Frame: Baseline and 2 months after intervention
|
The Mini Nutritional Assessment-Short Form (MNA-SF) ranges from 0 to 14, with higher scores indicating better nutritional status.
|
Baseline and 2 months after intervention
|
|
Study of Osteoporotic Fractures Index (SOF)
Time Frame: Baseline and 2 months after intervention
|
The Study of Osteoporotic Fractures (SOF) index assesses frailty status, with higher scores indicating greater frailty.
|
Baseline and 2 months after intervention
|
|
Sarcopenia Screening Scale with Calf Circumference (SARC-CalF)
Time Frame: Baseline and 2 months after intervention
|
The SARC-CalF is a screening tool ranging from 0 to 20, with higher scores indicating greater risk of sarcopenia.
|
Baseline and 2 months after intervention
|
|
Health behavior change (knowledge, attitude, and practice)
Time Frame: Baseline and 2 months
|
Health behavior change will be assessed using a structured questionnaire evaluating knowledge, attitude, and practice (KAP) related to nutrition.
The total score is calculated based on participants' responses, with higher scores indicating better health-related knowledge, attitudes, and behaviors.
|
Baseline and 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation rate in risk screening
Time Frame: up to 1 month
|
Participation rate in risk screening is defined as the proportion of older adults who participated in risk detection among the eligible population.
This measure reflects program implementation progress and community mobilization.
|
up to 1 month
|
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Coverage rate of nutritional intervention
Time Frame: Up to 2 months
|
Coverage rate of nutritional intervention is defined as the proportion of older adults who received nutritional intervention among those identified as at risk.
This measure reflects program effectiveness and coverage across communities.
|
Up to 2 months
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Frailty
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Epidemiologic Measurements
- Nutrition Assessment
Other Study ID Numbers
- N202504135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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