Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001017516
Ethics application status
Approved
Date submitted
31/07/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a tailored weekly meal box delivery service addressing quality of life and nutritional intake for people with Acquired Brain Injury in Western Australia
Scientific title
Feasibility of a tailored weekly meal box delivery service addressing quality of life and nutritional intake for people with Acquired Brain Injury in Western Australia
Secondary ID [1] 312660 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 334628 0
Condition category
Condition code
Neurological 331210 331210 0 0
Other neurological disorders
Diet and Nutrition 331211 331211 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the feasibility of a weekly meal box that is specifically tailored to those living with a neurological condition. The meal box has been developed based on feedback from co-design workshops with members of the neurological community (those living with a neurological condition who will be the consumers); health professionals working with people with neurological conditions (dietitians, speech pathologists, occupational therapists, psychologists, clinical specialists); and an existing meal box service provider (You Plate It, Perth). The meal boxes will be provided for one week and will comprise recipes and ingredients for 5 main meals, for up to four persons. In consultation with You Plate It chefs, the recipes have been selected by dietitians to ensure that they meet Australian Dietary Guidelines, whilst following the suggestions of the neurological community to be appealing and not too complex. Recipe instructions will be clear and easy to follow and supported with pictorial images. Ingredients will be pre-prepared to help overcome motor and cognitive limitations and other concerns raised during the co-design workshops.
15 people with Acquired Brain Injury (ABI) who are living in the community with their family will be invited to participate via our not-for-profit partner (Synapse). During the week prior to receiving the weekly meal box, participants will be invited to attend a simulation event at ECU to familiarise themselves with an example meal box. They will also attend an interview with the study’s dietitian to investigate their normal behaviours associated with mealtimes, including habitual intakes. At these interviews, participants will select their preferred recipes for the following week, to be included in their meal box that will be provided by our industry partner via their usual weekly delivery service. During the week-long trial, participants will be supported by study investigators and will be asked to complete a daily survey about their experience with the meal box as well as attending a final interview with the study dietitian, in the week after the trial.
Intervention code [1] 329179 0
Behaviour
Intervention code [2] 329180 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338981 0
Process feasibility
Timepoint [1] 338981 0
At the conclusion of the study.
Primary outcome [2] 339109 0
Resource feasibility
Timepoint [2] 339109 0
At the conclusion of the study
Primary outcome [3] 339110 0
Management feasibility
Timepoint [3] 339110 0
At the conclusion of the study. In the case of any adverse events, these will be handled and reported at the time they occur throughout the study.
Secondary outcome [1] 438601 0
Scientific feasibility. This is a primary outcome.
Timepoint [1] 438601 0
Adverse events may be reported at any time during the trial period, whilst participant experiences will be reported during the week-long trial and at the post-trial interview.
Secondary outcome [2] 438602 0
Change in the mealtime-related impact on quality of life in people living with ABI and their family members.
Timepoint [2] 438602 0
Once during the week prior to commencement with the meal box and once during the week following the week-long trial.
Secondary outcome [3] 438603 0
Change in the mealtime-related impact on activities of daily living in people living with ABI and their family members.
Timepoint [3] 438603 0
Once during the week prior to commencement with the meal box and once during the week following the week-long trial.
Secondary outcome [4] 438604 0
Change in nutritional intake.
Timepoint [4] 438604 0
Once during the week prior to commencement with the meal box and once during the week following the week-long trial.

Eligibility
Key inclusion criteria
Individuals with ABI living in the community with their family
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of access to functional food storage and cooking facilities within the home
Inability to follow instructions/recipes
Restrictive food allergy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317092 0
University
Name [1] 317092 0
Edith Cowan University
Country [1] 317092 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 319348 0
None
Name [1] 319348 0
Address [1] 319348 0
Country [1] 319348 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315841 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 315841 0
Ethics committee country [1] 315841 0
Australia
Date submitted for ethics approval [1] 315841 0
05/04/2024
Approval date [1] 315841 0
01/05/2024
Ethics approval number [1] 315841 0
REMS No: 2023-04908-REES

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135970 0
Dr Joanna Rees
Address 135970 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 135970 0
Australia
Phone 135970 0
+61 0403872227
Fax 135970 0
Email 135970 0
[email protected]
Contact person for public queries
Name 135971 0
Joanna Rees
Address 135971 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 135971 0
Australia
Phone 135971 0
+61 0403872227
Fax 135971 0
Email 135971 0
[email protected]
Contact person for scientific queries
Name 135972 0
Joanna Rees
Address 135972 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 135972 0
Australia
Phone 135972 0
+61 0403872227
Fax 135972 0
Email 135972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.