NCT07504419

Brief 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. Design thinking is used to design product/service processes based on nutritional problems, and combined with the nutritional care process.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 21, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Older adultsFrailtyFrailty preventionDesign thinkingCommunity-based nutrition care modelIntegrated Care for Older People (ICOPE)

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Baseline and 2 months

Secondary Outcomes (2)

  • Participation rate in risk screening

    up to 1 month

  • Coverage rate of nutritional intervention

    Up to 2 months

Study Arms (1)

nutrition education

EXPERIMENTAL
Other: nutrition education

Interventions

Nutrition education course design will be based on interview results with subjects with high risk of frailty.

nutrition education

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who cannot eat independently, such as those who rely on nasogastric tubes for feeding.
  • Those who cannot express their opinions independently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dingshuo Village Residential Center

New Taipei City, Wanhua District, 10860, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Research Center of Geriatric Nutrition, Taipei Medical University

Study Record Dates

First Submitted

March 21, 2026

First Posted

March 31, 2026

Study Start

July 4, 2025

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations