NCT05922098

Brief Summary

In 2020, we have entered an aging society. During the aging process, the body will decline with age, and the muscles will decrease, which will affect the swallowing muscles, causing chewing and swallowing difficulties are very common. Difficulty masticating is associated with problems with real teeth, dentures, and oral health disease, and is associated with infection, pain, inadequate nutritional intake, affected appearance, decreased quality of life, and mortality. At present, Taiwan mostly provides the elderly with shredded food, cooked soft and rotten food, or whipped food. However, when the food is mashed or shredded, the original color, fragrance, and taste of the food will be lost. It cannot change the appetite of the elderly, and it will reduce the satisfaction of the elderly's meal, and there will still be risks of insufficient food intake and uneven nutrition. Appearance or taste can improve the satisfaction and quality of life of the elderly, improve the health needs of nutrition, and allow a variety of choices when eating to change the current situation of traditional whipped food and shredded meals.It is expected that the quality of life, nutritional status, and meal satisfaction of the pre-frail elders with masticatory difficulties will be significantly higher than those of the control group if the subjects receive care meals, which can be used as a reference for the daily care of the elderly with masticatory disorders in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

First Submitted

Initial submission to the registry

May 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

May 2, 2023

Last Update Submit

November 12, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Geriatric oral health assessment index,GOHAI

    Total score is 64 points, with higher scores indicating poorer oral health

    10-20mins

  • Oral Health Assessment Tool ,OHAT

    Total score is 16 points, with higher scores indicating poorer oral health

    10-20mins

  • Oral health impact profile,OHIP

    Total score is 56 points, with higher scores indicating poorer oral health

    10-20mins

  • Meal satisfaction seven-item questionnaire

    full score 35, minimum score 5 points.

    5-10mins

Secondary Outcomes (1)

  • Mini Nutritional Assessment - MNA Elderly,

    5-10mins

Study Arms (2)

experimental group

EXPERIMENTAL

Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)

Other: Texture Modified Foods Manual for chewing dysfunctions in older adult

control group

NO INTERVENTION

Traditional Soft Food Care Manual

Interventions

Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)

experimental group

Eligibility Criteria

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

You may qualify if:

  • Elderly over 65 years old.
  • Elders who are pre-frail cases after the five assessments of frailty and who are abnormal after the chewing test.
  • Clear awareness, willing to accept visitors, able to communicate in Chinese and Taiwanese.
  • Ability to express food appearance and taste.
  • Those who eat by mouth.

You may not qualify if:

  • Elderly with dementia (certified by medical records and disability handbook).
  • Elderly people who have swallowing disorders in the throat stage after being screened by the modified water swallowing test.
  • Visually impaired and no primary caregiver to assist the program implementer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WangJiaJie

Hualien City, 970, Taiwan

Location

MeSH Terms

Conditions

Food Preferencesnigropallidal encephalomalaciaPersonal Satisfaction

Interventions

Aging

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Wang JiaJie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2023

First Posted

June 28, 2023

Study Start

June 7, 2023

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations