NCT07265726

Brief Summary

After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. For individuals who meet the inclusion criteria and express interest, the principal investigator will verbally explain the study protocol, go over the informed consent form, and answer any related questions. Potential participants who meet the inclusion criteria and are willing to participate will be given time to consider their involvement in the study. Inclusion criteria for this study are:

  1. 1.Adults aged 40 and older
  2. 2.Ability to hear, speak, and read Chinese, and communicate fluently in Mandarin or Taiwanese.
  3. 3.Being completely edentulous and not using dentures;
  4. 4.Having severe food allergies, renal failure, or dysphagia;
  5. 5.Being diagnosed with terminal illness under palliative care, severe mental illness, or cognitive impairment;
  6. 6.Having a serious health condition that prevents standing or performing oral self-care behaviors.
  7. 7.intentional interviews combined with expressive arts activities,
  8. 8.expressive arts activities only, or
  9. 9.control group.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

December 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 13, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • sarcopenia risk

    This study adopted the SARC-F questionnaire proposed by the Asian Working Group for Sarcopenia (AWGS). The tool consists of five questions aimed at assessing muscle function, including grip strength, endurance, walking ability, ability to stand up from a chair, and fall history in the past six months (Ishida et al., 2020). The first four items are scored based on the responses: no difficulty (0 points), some difficulty (1 point), and a lot of difficulty (2 points). The fifth item, fall history, is scored as follows: 0 falls = 0 points, 1-3 falls = 1 point, and 4 or more falls = 2 points. The total score ranges from 0 to 10, with higher scores indicating a greater risk of sarcopenia. A SARC-F score of 4 or higher suggests a positive result for self-screening, indicating the need for further medical evaluation and appropriate diagnostic and treatment interventions. The sensitivity, specificity, and positive/negative likelihood ratios of the SARC-F for predicting sarcopenia and its risk

    baseline, one week after the intervention, and at a one-month follow-up

  • eating assessment

    This study utilized the Eating Assessment Tool-10 (EAT-10), a dysphagia screening tool included in the adult oral health assessment form issued by the Department of Oral Health, Ministry of Health and Welfare. The version used is the Chinese translation by Huang (2023) of the original tool developed by Belafsky et al. (2008). The EAT-10 consists of 10 items that assess self-perceived difficulties related to swallowing, encompassing physical, psychological, and social aspects. Example items include: "Swallowing problems have caused me to lose weight" and "Swallowing interferes with my ability to go out for meals." The scale has demonstrated good reliability and validity, with a Cronbach's alpha coefficient of 0.92. The total score ranges from 0 to 40, with a score of ≥3 indicating the presence of swallowing difficulties. Higher scores reflect a greater risk of oral frailty.

    baseline, one week after the intervention, and at a one-month follow-up

  • grit

    This study adopted the Chinese version of the Grit Scale (Grit-10) developed by Duckworth et al. (2009). The scale consists of 10 items across two main factors: passion (reverse-scored items) and perseverance. Example items include: "I often set a goal but later choose to pursue a different one" (passion, reverse-scored) and "I finish whatever I begin" (perseverance). The scale uses a 5-point Likert rating system, ranging from 1 (not at all like me) to 5 (very much like me). Scoring is as follows: each item has a maximum score of 5. Odd-numbered items are reverse scored, and even-numbered items are positively scored. The total score of the odd-numbered items divided by 5 gives the passion subscale score, while the total score of the even-numbered items divided by 5 gives the perseverance subscale score. The sum of all 10 items divided by 10 yields the overall grit score. Lin (2019) applied this Chinese version to university students and reported a Cronbach's alpha of 0.84 for the ov

    baseline, one week after the intervention, and at a one-month follow-up

  • oral health literacy

    This study adopted the short-form Health Literacy Dental Scale (HeLD-14) developed by Jones et al. (2015), which has a Cronbach's alpha of 0.87. The scale was translated into Simplified Chinese by Liu et al. (2021) (Chinese version of HeLD, HeLD-C), showing a Cronbach's alpha of 0.92, and was later adapted into a Traditional Chinese version by Cheng (2023). The Traditional Chinese version includes 13 items across seven domains: Receptivity (e.g., "I care about my dental or oral health needs"), Understanding (e.g., "I can fill out dental-related forms"), Support (e.g., "I can bring family members or friends to dental visits"), Economic Barriers (e.g., "I can afford the cost of dental or oral health care"), Utilization (e.g., "I know how to make a dental appointment"), Communication (e.g., "I can obtain alternative oral health opinions from other dentists"), and Access to Resources (e.g., "I can follow the dentist's instructions"). The scale uses a 5-point Likert rating system r

    baseline, one week after the intervention, and at a one-month follow-up

  • oral self-care behaviors

    This study adopted the Oral Self-Care Behavior Scale revised by Cheng (2023), originally developed by Ho, Rita Chang et al. (2019). The scale consists of 10 items; example statements include: "I brush my teeth at least twice a day" and "I always brush my teeth before going to bed at night." A 4-point Likert scale is used, ranging from 1 (not at all) to 4 (completely). The total score ranges from 10 to 40, with higher scores indicating better oral self-care behavior. The Cronbach's alpha ranges from 0.78 to 0.87 (Cheng, 2023), demonstrating good reliability.

    baseline, one week after the intervention, and at a one-month follow-up

Study Arms (3)

Control Group

NO INTERVENTION

Participants in the control group will not receive any intentional interview or expressive arts activity during the 6-week intervention period. They will receive oral health education after the same time interval as the experimental arms, ensuring consistency in outcome measurement.

Expressive Arts Activities Only

ACTIVE COMPARATOR

Participants in this arm will engage only in expressive arts activities over a 6-week period. These activities are designed to foster creative engagement and emotional well-being. After the intervention, participants will receive the same oral health education provided to all groups.

Behavioral: Intentional Interview

Intentional Interview + Expressive Arts Activities

EXPERIMENTAL

Participants in this arm will receive an intervention combining an intentional interview based on the Intentionality Matrix of Healing framework with expressive arts activities. The intentional interview is designed to guide participants in reflecting on personal health-related intentions, while the expressive arts component facilitates emotional expression and engagement. After the 6-week intervention, all participants will also receive standardized oral health education.

Behavioral: Intentional InterviewBehavioral: Expressive Arts Activities

Interventions

Participants in this arm will receive an intervention

Expressive Arts Activities OnlyIntentional Interview + Expressive Arts Activities

Participants in this arm will engage only in expressive arts activities over a 6-week period.

Intentional Interview + Expressive Arts Activities

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 40 years or older (Vlietstra et al., 2024).
  • Ability to hear, speak, and read Chinese, with no communication barriers in Mandarin or Taiwanese.

You may not qualify if:

  • Edentulous individuals who do not use dentures.
  • Individuals with severe food allergies, renal failure, or dysphagia.
  • Individuals diagnosed with terminal illness under palliative care, severe psychiatric disorders, or cognitive impairments.
  • Individuals with serious medical conditions that prevent standing or performing oral self-care behaviors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanzhi

New Taipei City, New Taipei City, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2025

First Posted

December 5, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

December 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations