Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000985583
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
13/08/2024
Date last updated
13/04/2025
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a tailored weekly meal box delivery service addressing nutritional intake and quality of life in the Western Australian neurological community
Scientific title
Feasibility of a tailored weekly meal box delivery service addressing nutritional intake and quality of life in the Western Australian neurological community
Secondary ID [1] 311952 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Brain Bites
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological condition 333549 0
Condition category
Condition code
Diet and Nutrition 330233 330233 0 0
Other diet and nutrition disorders
Neurological 331199 331199 0 0
Neurodegenerative diseases

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 early-stage Huntington's Disease who are living in the community with their family will be invited to participate via our not-for-profit partner (Huntington’s Australia). 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] 328411 0
Behaviour
Intervention code [2] 328412 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337982 0
Process, resource, management and scientific feasibility assessed as a composite outcome
Assessment method [1] 337982 0
Primary assessment Method: Process feasibility includes measuring how effectively we can recruit participants and keep them engaged. This includes how people react to our invitation to the study, how many remain interested after we explain what's involved, and how many are suitable to take part. Evaluation of the process metric will involve an audit of participant recruitment and retention data (number referred, number eligible, number enrolled, number of withdrawals, trial recruitment rate, trial completion rate). Resource feasibility involves measuring the effort and costs related to using the meal box encompassing keeping participants engaged. Evaluation of the methods used to communicate with participants throughout the trial, as well as encouraging compliance with the meal preparation and cooking will be measured via the post-trial questionnaire. In addition, evaluation of the resource metric relating to setting up and running the trial will involve an audit of communication with participants and staff (the method and time spent communicating with staff and participants will be recorded), as well as all monetary costs involved with execution of the research. Management feasibility involves an audit of research ethics and governance approval procedures, staff preparation time for participant communication, time and accuracy in data collection/entry and the reporting and handling of adverse events outlined in Hazard Risk Assessment- Ref No: 4544. Scientific feasibility involves an audit of any adverse events (should they occur) for example the risk of illness due to exposure to food allergens or contaminated food, with an additional audit of participant experiences, burden, adherence and compliance to the intervention using a study specific questionnaire. Participant experiences will be captured during the trial via surveys and post-trial via semi-structured interviews. These will involve probing barriers and motivators to engagement and perceived positive and negatives about the meal box. This information will enable us to ensure that the meal box is safe to use, evaluate how easy it is for participants to use the meal box without undue fatigue or cognitive demand, and check if participants stick to the intended use of the meal box.
Timepoint [1] 337982 0
Process feasibility, resource feasibility and management feasibility timepoints are at the conclusion of the study. 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 [1] 433990 0
Change in the mealtime-related impact on quality of life in people living with early-stage Huntington's Disease and their family members.
Assessment method [1] 433990 0
EQ-5D-5L. The EQ-5D-5L descriptive system comprises five dimensions of health MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. In addition, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions ( EuroQol Research Foundation. EQ-5D-5L User Guide, 2019. Available from: https://euroqol.org/publications/user-guides)
Timepoint [1] 433990 0
Pre and Post trial
Secondary outcome [2] 438126 0
Change in nutritional intake
Assessment method [2] 438126 0
Food frequency questionnaire designed specifically for this study.
Timepoint [2] 438126 0
Pre and Post trial
Secondary outcome [3] 438321 0
Change in the mealtime-related impact on activities of daily living in people living with early-stage Huntington's Disease and their family members.
Assessment method [3] 438321 0
Study-specific questionnaire
Timepoint [3] 438321 0
Pre and post trial

Eligibility
Key inclusion criteria
Individuals with early-stage Huntington's Disease who are 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
Requirement for texture modified foods (later stages of Huntington's Disease (HD)
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
Completed
Date of first participant enrolment
Anticipated
23/09/2024
Actual
23/09/2024
Date of last participant enrolment
Anticipated
28/10/2024
Actual
28/10/2024
Date of last data collection
Anticipated
31/12/2024
Actual
30/11/2024
Sample size
Target
15
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316291 0
University
Name [1] 316291 0
Edith Cowan University
Country [1] 316291 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Country
Australia
Secondary sponsor category [1] 319340 0
None
Name [1] 319340 0
Country [1] 319340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315110 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 315110 0
Ethics committee country [1] 315110 0
Australia
Date submitted for ethics approval [1] 315110 0
05/04/2024
Approval date [1] 315110 0
01/05/2024
Ethics approval number [1] 315110 0
REMS No: 2023-04908-REES

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 133702 0
Dr Joanna Rees
Address 133702 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 133702 0
Australia
Phone 133702 0
+61 0403872227
Email 133702 0
j.rees@ecu.edu.au
Contact person for public queries
Name 133703 0
Joanna Rees
Address 133703 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 133703 0
Australia
Phone 133703 0
+61 0403872227
Email 133703 0
j.rees@ecu.edu.au
Contact person for scientific queries
Name 133704 0
Joanna Rees
Address 133704 0
Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027
Country 133704 0
Australia
Phone 133704 0
+61 0403872227
Email 133704 0
j.rees@ecu.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.