Food SelectionNCT05922098
Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
A study testing Texture Modified Foods Manual for chewing dysfunctions in older adult in people with Food Selection and Quality of Life, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Selection, Quality of Life, Chewing Disease
- What is being tested?
- Texture Modified Foods Manual for chewing dysfunctions in older adult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2023to 31 Aug 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Explore the Effect of Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
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.
- Conditions
- Food Selection, Quality of Life, Chewing Disease, Satisfaction
- Being tested
- Texture Modified Foods Manual for chewing dysfunctions in older adult
- Medical subject headings
- Food Preferences, nigropallidal encephalomalacia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texture Modified Foods Manual for chewing dysfunctions in older adultOther
Texture Modified Foods Manual for chewing dysfunctions (including IDDSI)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Texture Modified Foods Manual for chewing dysfunctions (including IDDSI) Receives: Other: Texture Modified Foods Manual for chewing dysfunctions in older adult |
| control group | No intervention | Traditional Soft Food Care Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric oral health assessment index，GOHAI
Total score is 64 points, with higher scores indicating poorer oral health
Measured: 10-20mins
Oral Health Assessment Tool ，OHAT
Total score is 16 points, with higher scores indicating poorer oral health
Measured: 10-20mins
Oral health impact profile，OHIP
Total score is 56 points, with higher scores indicating poorer oral health
Measured: 10-20mins
Meal satisfaction seven-item questionnaire
full score 35, minimum score 5 points.
Measured: 5-10mins
Secondary outcomes (1)
Mini Nutritional Assessment - MNA Elderly,
Less than or equal to 7 points for malnutrition; 8-11 points for high-risk groups of malnutrition; 12 points for normal.
Measured: 5-10mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start7 Jun 2023
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WangJiaJie, National Taipei University of Nursing and Health Sciences
- Investigators
- Wang JiaJie, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922098
- Sponsor's protocol ID
- WangJiaJie
- Status last verified
- Nov 2024
- First submitted
- 2 May 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effect of Improved Modified Care Meals to Improving the Quality Of Life of the Pre-Frailty Chewing Disorders of the Older Adult
- ClinicalTrials.gov ID
- NCT05922098
- Acronym / sponsor ID
- WangJiaJie
- Conditions
- Food Selection, Quality of Life, Chewing Disease, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Jun 2023 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Texture Modified Foods Manual for chewing dysfunctions in older adultTexture Modified Foods Manual for chewing dysfunctions (including IDDSI) |
| control group | No intervention | –Traditional Soft Food Care Manual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Texture Modified Foods Manual for chewing dysfunctions in older adultTexture Modified Foods Manual for chewing dysfunctions (including IDDSI) | Other | experimental group |
Primary outcome
Geriatric oral health assessment index，GOHAI
Time frame: 10-20mins
Total score is 64 points, with higher scores indicating poorer oral health
Oral Health Assessment Tool ，OHAT
Time frame: 10-20mins
Total score is 16 points, with higher scores indicating poorer oral health
Oral health impact profile，OHIP
Time frame: 10-20mins
Total score is 56 points, with higher scores indicating poorer oral health
Meal satisfaction seven-item questionnaire
Time frame: 5-10mins
full score 35, minimum score 5 points.
1 secondary outcome
Mini Nutritional Assessment - MNA Elderly,
Time frame: 5-10mins
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 14 Nov 2024.
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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.
Wang JiaJie principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Texture Modified Foods Manual for chewing dysfunctions in older adult in people with Food Selection and Quality of Life, run by National Taipei University of Nursing and Health Sciences 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 5 inclusion and 3 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 14 Nov 2024. 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?
Geriatric oral health assessment index，GOHAI (time frame: 10-20mins). The study lists 4 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 14 Nov 2024.