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NCT Number: NCT07504419

A Nutrition Care Model for Frailty Prevention in the Elderly Based on Design Thinking

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.

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Key information

Conditions

Malnutrition Elderly Frailty Frailty Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Sarcopenia in Elderly

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dingshuo Village Residential Center

New Taipei City, Wanhua District, 10860, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition education

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Suh-Ching, Yang

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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