Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000514101
Ethics application status
Approved
Date submitted
27/03/2019
Date registered
1/04/2019
Date last updated
12/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of plate waste and reasons for plate waste in maternity patients using a room service model (a la carte menu) and a 14-day cyclical menu.
Scientific title
Comparison of plate waste and reasons for plate waste in maternity patients using a hybrid room service model (a la carte menu) and a 14-day cyclical menu .
Secondary ID [1] 297766 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal nutrition 312105 0
Condition category
Condition code
Reproductive Health and Childbirth 310664 310664 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be an observational study in which postnatal patient plate wastage (ie. food and drink uneaten) will be observed. As part of a hospital initiated trial, the a la carte menu group will order breakfast and lunch from the hospital 14-day cyclical menu and their evening meal will be from the new a la carte menu. They will receive morning tea and afternoon tea as per usual service delivery. The cyclical menu group will be postnatal patients on a separate ward who will continue to order breakfast, lunch and dinner each day as part of the 14-day cyclical menu as per standard care. They will receive morning tea, afternoon tea and supper as per usual service delivery. All participants will be asked to complete a questionnaire relating to the reasons for not completing the food or drink supplied on their evening meal tray. The observation period will be one point in time per patient (dinner). The total study will be conducted over 4-5 weeks.
Intervention code [1] 314000 0
Not applicable
Comparator / control treatment
The cyclical menu group will be postnatal patients on a separate ward who will continue to order breakfast, lunch and dinner each day as part of the 14-day cyclical menu as per standard care. They will receive morning tea, afternoon tea and supper as per usual service delivery. All participants will be asked to complete a questionnaire relating to the reasons for not completing the food or drink supplied on their evening meal tray. The observation period will be one point in time per patient (dinner). The total study will be conducted over 4-5 weeks.
Control group
Active

Outcomes
Primary outcome [1] 319508 0
1. Change in percentage plate wastage using a 5-point nominal visual plate wastage tool commonly used in practice and has been published in large national and international studies.
Timepoint [1] 319508 0
Photographs will be taken on the day of plate waste audit (pre and post meal consumption) and plate wastage will be calculated during or upon completion of data collection.
Primary outcome [2] 319509 0
2. Patients' reasons for plate wastage and overall satisfaction with the meal via a short paper-based questionnaire designed specifically for the study.
Timepoint [2] 319509 0
The evening of the audit or the following morning.
Primary outcome [3] 319510 0
3. Evaluate average nutrient intake between food service models using recipe and item analysis via Foodworks dietary analysis software.
Timepoint [3] 319510 0
At the conclusion of data collection.
Secondary outcome [1] 368512 0
Nil
Timepoint [1] 368512 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria:
i. Postnatal patients on a la carte menu
ii. Ward diet allocation of either standard, vegetarian, vegan, gluten free or receiving the 14-day cyclical menu
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
i. Antenatal or other reason for admission
ii. Ward diet allocation for all other therapeutic diets not listed in the inclusion criterion
iii. Multiple food allergens
iv. Day 4 following an uncomplicated caesarian and day 3 following an uncomplicated vaginal delivery (due to likely discharge the following day)
v. Post-delivery mental health issues or complex medical and social situations

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using the IBM SPSS statistical analysis package. Descriptive statistics including frequencies and relative percentages will be calculated. Normality tests will be undertaken with log-transformation as required. Independent samples t-tests will be conducted between the intervention group and the control group to analyse continuous data, together with Pearson’s chi squared test to assess associations between categorical variables. P < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/04/2019
Actual
Date of last participant enrolment
Anticipated
23/04/2019
Actual
Date of last data collection
Anticipated
24/04/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13458 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 26065 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 302290 0
Hospital
Name [1] 302290 0
St John of God Hospital Subiaco
Country [1] 302290 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hospital Subiaco
Address
12 Salvado Road, Subiaco, WA, 6008
Country
Australia
Secondary sponsor category [1] 302165 0
None
Name [1] 302165 0
Nil
Address [1] 302165 0
Nil
Country [1] 302165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302967 0
St John of God Health Care Human Reseach Ethics Committee
Ethics committee address [1] 302967 0
12 Salvado Road, Subiaco, 6008, Western Australia
Ethics committee country [1] 302967 0
Australia
Date submitted for ethics approval [1] 302967 0
06/03/2019
Approval date [1] 302967 0
18/03/2019
Ethics approval number [1] 302967 0

Summary
Brief summary
This observational study will compare evening meal plate wastage between a group receiving an a la carte dinner menu and a group receiving a cyclical dinner menu (pre-ordered) on two maternity wards at St John of God Subiaco Hospital, Perth, Western Australia. The hospital has initiated a three-month trial of a new menu model (a la carte). Researchers will observe the impact of this change, and compare with cyclical menus with regards to the main reasons for plate wastage (i.e. food and drink uneaten) from a patient’s perspective. At the conclusion of data collection and analysis the data will be assessed and used to provide average plate waste and average nutrient intake data, as well as patient comments analysed to assist with the evaluation of the new hybrid room service model (a la Carte menu) trial.
Primary research hypothesis: Patients who consume an a la carte dinner will have less plate wastage compared to those on the 14-day cyclical menu.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92010 0
Ms Tammy Hine
Address 92010 0
St John of God Subiaco Hospital
12 Salvado Road, Subiaco, 6008, Western Australia
Country 92010 0
Australia
Phone 92010 0
+61 893826070
Fax 92010 0
Email 92010 0
tammy.hine@sjog.org.au
Contact person for public queries
Name 92011 0
Ms Tammy Hine
Address 92011 0
St John of God Subiaco Hospital
12 Salvado Road, Subiaco, 6008, Western Australia
Country 92011 0
Australia
Phone 92011 0
+61 893826070
Fax 92011 0
Email 92011 0
tammy.hine@sjog.org.au
Contact person for scientific queries
Name 92012 0
Ms Tammy Hine
Address 92012 0
St John of God Subiaco Hospital
12 Salvado Road, Subiaco, 6008, Western Australia
Country 92012 0
Australia
Phone 92012 0
+61 893826070
Fax 92012 0
Email 92012 0
tammy.hine@sjog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will not be individually identifiable. Quantitative and qualitative data will be pooled for analysis, and these results reported.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.