Food PreferencesNCT04298788
Food Intake and Blue Dishware in Residents Living With Dementia
A study testing Blue dishware in people with Food Preferences and Eating Behavior, run by University of Waterloo at 1 site in Canada.
Trial summary
Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Food Preferences, Eating Behavior
- What is being tested?
- Blue dishware
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 1 Feb 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- living in a residential care environment with dementia
- informed consent of POA and assent of person living with dementia
Who cannot join
- did not come to the dining room to eat
- required eating assistance
- did not live on the study unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Intake and Blue Dishware in Residents Living With Dementia in Retirement Homes
Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Within-participant comparisons were made to determine if food intake and eating challenges improved with the blue dishware condition.
- Conditions
- Food Preferences, Eating Behavior
- Being tested
- Blue dishware
- Medical subject headings
- Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue dishwareOther
blue dishware is used for plates and bowls
| Study group | Role | What they receive |
|---|---|---|
| White dishware | Placebo comparator | standard white dishware used in the home Receives: Other: Blue dishware |
| blue dishware | Experimental | specially designed blue dishware, plates and bowls Receives: Other: Blue dishware |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precent of Food consumed of food served (grams consumed/grams provided)
gram weight of food intake as weighed on a calibrated scale
Measured: 8 weeks
Secondary outcomes (1)
Percent of Meals with an Eating challenge based on an Eating challenges Checklist
change in eating challenges from a prespecified list
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Aug 2019
- Primary completion30 Sep 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food PreferencesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- participant meals were randomized to blue or white dishware conditions, matched for food choices
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Keller, University of Waterloo
- Investigators
- Heather Keller, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298788
- Sponsor's protocol ID
- ORE40986
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnelly R, Wei C, Morrison-Koechl J, Keller H. The effect of blue dishware versus white dishware on food intake and eating challenges among residents living with dementia: a crossover trial. BMC Res Notes. 2020 Jul 23;13(1):353. doi: 10.1186/s13104-020-05195-y.
PubMed 32703270
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake and Blue Dishware in Residents Living With Dementia in Retirement Homes
- ClinicalTrials.gov ID
- NCT04298788
- Acronym / sponsor ID
- ORE40986
- Conditions
- Food Preferences, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 6 Mar 2020 (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.
Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Within-participant comparisons were made to determine if food intake and eating challenges improved with the blue dishware condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participant meals were randomized to blue or white dishware conditions, matched for food choices
| Arm | Type | Receives |
|---|---|---|
| White dishware | Placebo comparator | Other: Blue dishwarestandard white dishware used in the home |
| blue dishware | Experimental | Other: Blue dishwarespecially designed blue dishware, plates and bowls |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- living in a residential care environment with dementia
- informed consent of POA and assent of person living with dementia
Key exclusion criteria (3 listed)
- did not come to the dining room to eat
- required eating assistance
- did not live on the study unit
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 |
|---|---|---|
| Blue dishwareblue dishware is used for plates and bowls | Other | White dishware, blue dishware |
Primary outcome
Precent of Food consumed of food served (grams consumed/grams provided)
Time frame: 8 weeks
gram weight of food intake as weighed on a calibrated scale
1 secondary outcome
Percent of Meals with an Eating challenge based on an Eating challenges Checklist
Time frame: 8 weeks
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 6 Mar 2020.
- Derived from this study: PubMed 32703270Donnelly R, Wei C, Morrison-Koechl J, Keller H. The effect of blue dishware versus white dishware on food intake and eating challenges among residents living with dementia: a crossover trial. BMC Res Notes. 2020 Jul 23;13(1):353. doi: 10.1186/s13104-020-05195-y.
- Individual participant dataSharing planned: No
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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.
Heather Keller principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue dishware in people with Food Preferences and Eating Behavior, run by University of Waterloo at 1 site in Canada.
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 2 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 6 Mar 2020. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Precent of Food consumed of food served (grams consumed/grams provided) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298788, which also lists 1 linked publication.
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 6 Mar 2020.