Malnutrition ElderlyNCT07504419
A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking
A study testing nutrition education in people with Malnutrition Elderly and Sarcopenia in Elderly, run by Suh-Ching, Yang at 1 site in Taiwan.
Trial summary
This international multicenter study project. A physical function screening activity for the elderly will be held in the community centers. After screening out high-risk subjects for frailty, they will be guided to participate in motivational interviews. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition Elderly, Sarcopenia in Elderly, Frailty Syndrome
- What is being tested?
- nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jul 2025to 29 Aug 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Those who cannot eat independently, such as those who rely on nasogastric tubes for feeding.
- Those who cannot express their opinions independently.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dingshuo Village Residential Center
New Taipei City, Wanhua District, 10860
About this study
Official title: A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking: A Comparative Analysis of Community Practices in Taiwan and Japan
This international multicenter study project. A physical function screening activity for the elderly will be held in the community centers. After screening out high-risk subjects for frailty, they will be guided to participate in motivational interviews. Design thinking is used to design product/service processes based on nutritional problems, and combined with the nutritional care process.
Read the 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.
- Being tested
- nutrition education
- Keywords
- Older adults, Frailty, Frailty prevention, Design thinking, Community-based nutrition care model, Integrated Care for Older People (ICOPE)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition educationOther
Nutrition education course design will be based on interview results with subjects with high risk of frailty.
| Study group | Role | What they receive |
|---|---|---|
| nutrition education | Experimental | Not described Receives: Other: nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing function
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.
Measured: Baseline and 2 months after intervention
Eating Assessment Tool-10 (EAT-10)
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.
Measured: Baseline and 2 months after intervention
Mini Nutritional Assessment-Short Form (MNA-SF)
The Mini Nutritional Assessment-Short Form (MNA-SF) ranges from 0 to 14, with higher scores indicating better nutritional status.
Measured: Baseline and 2 months after intervention
Study of Osteoporotic Fractures Index (SOF)
The Study of Osteoporotic Fractures (SOF) index assesses frailty status, with higher scores indicating greater frailty.
Measured: Baseline and 2 months after intervention
Sarcopenia Screening Scale with Calf Circumference (SARC-CalF)
The SARC-CalF is a screening tool ranging from 0 to 20, with higher scores indicating greater risk of sarcopenia.
Measured: Baseline and 2 months after intervention
Health behavior change (knowledge, attitude, and practice)
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.
Measured: Baseline and 2 months
Secondary outcomes (2)
Participation rate in risk screening
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.
Measured: up to 1 month
Coverage rate of nutritional intervention
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start4 Jul 2025
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition ElderlyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For subjects who meet the high risk of frailty after screening with the ICOPE scale, a one-on-one interview will be arranged to gain a deeper understanding of their nutrition-related issues and individual needs. The interview results will serve as the basis for designing nutrition education courses. Subjects are required to complete questionnaires before and after participation and undergo physiological function and health behavior assessments to understand the potential improvement effects of this care model on health behaviors and physical functions. The collected results will be compared with the results of Settsu City, Osaka, Japan.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suh-Ching, Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suh-Ching, Yang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504419
- Sponsor's protocol ID
- N202504135
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking: A Comparative Analysis of Community Practices in Taiwan and Japan
- ClinicalTrials.gov ID
- NCT07504419
- Acronym / sponsor ID
- N202504135
- Keywords
- Older adults, Frailty, Frailty prevention, Design thinking, Community-based nutrition care model, Integrated Care for Older People (ICOPE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Suh-Ching, YangUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 31 Mar 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.
This international multicenter study project. A physical function screening activity for the elderly will be held in the community centers. After screening out high-risk subjects for frailty, they will be guided to participate in motivational interviews. Design thinking is used to design product/service processes based on nutritional problems, and combined with the nutritional care process.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For subjects who meet the high risk of frailty after screening with the ICOPE scale, a one-on-one interview will be arranged to gain a deeper understanding of their nutrition-related issues and individual needs. The interview results will serve as the basis for designing nutrition education courses. Subjects are required to complete questionnaires before and after participation and undergo physiological function and health behavior assessments to understand the potential improvement effects of this care model on health behaviors and physical functions. The collected results will be compared with the results of Settsu City, Osaka, Japan.
| Arm | Type | Receives |
|---|---|---|
| nutrition education | Experimental | Other: nutrition education |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Those who cannot eat independently, such as those who rely on nasogastric tubes for feeding.
- Those who cannot express their opinions independently.
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 |
|---|---|---|
| nutrition educationNutrition education course design will be based on interview results with subjects with high risk of frailty. | Other | nutrition education |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Participation rate in risk screening
Time frame: up to 1 month
Coverage rate of nutritional intervention
Time frame: Up to 2 months
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 31 Mar 2026.
- Individual participant dataSharing planned: No
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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 nutrition education in people with Malnutrition Elderly and Sarcopenia in Elderly, run by Suh-Ching, Yang 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 2 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 31 Mar 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?
Chewing function (time frame: Baseline and 2 months after intervention). The study lists 6 primary outcomes in all. 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 31 Mar 2026.