- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298788
Food Intake and Blue Dishware in Residents Living With Dementia
March 5, 2020 updated by: Heather Keller, University of Waterloo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada
- Riverside Glen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- living in a residential care environment with dementia
- informed consent of POA and assent of person living with dementia
Exclusion Criteria:
- did not come to the dining room to eat
- required eating assistance
- did not live on the study unit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: White dishware
standard white dishware used in the home
|
blue dishware is used for plates and bowls
|
Experimental: blue dishware
specially designed blue dishware, plates and bowls
|
blue dishware is used for plates and bowls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Meals with an Eating challenge based on an Eating challenges Checklist
Time Frame: 8 weeks
|
change in eating challenges from a prespecified list
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather Keller, University of Waterloo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
February 22, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 5, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORE40986
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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