ANZCTR - Registration

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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

ACTRN12625000635460p

Ethics application status

Submitted, not yet approved

Date submitted

26/05/2025

Date registered

17/06/2025

Date last updated

17/06/2025

Date data sharing statement initially provided

17/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Brain Bites Huntington's Disease: A Mediterranean meal box for families

Scientific title

Brain Bites HD: Feasibility and preliminary effects of a Mediterranean meal box for Huntington’s disease families.

Secondary ID [1]

Not applicable

Universal Trial Number (UTN)

U1111-1323-3234

Trial acronym

Brain Bites HD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Huntington's Disease

Condition category

Condition code

Neurological

Neurodegenerative diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A Mediterranean meal box intervention will be provided over one-week to individuals with symptomatic Huntington’s disease. Meal boxes will be delivered on a Sunday by a commercial provider operating in Victoria and New South Wales. Each box will contain ingredients and recipes to prepare four main meals as well as kitchen safety tips and cooking strategies tailored to the needs of people living with Huntington’s disease. Participants will be asked to prepare the four meals during the working week using the provided ingredients and recipes. Throughout the intervention, participants will be asked to take photos of their ingredient set-up before cooking, the meal produced, the mess created during the cook and post eating and any food that was not eaten. They will also be asked to rate the difficulty of cooking and taste of the meal and provide any additional feedback they wish.

Examples of Meals and Ingredients
Participants will be presented with Mediterranean-style meals such as (only examples):

Grilled salmon with quinoa salad and roasted vegetables

Chickpea and vegetable stew with wholegrain bread

Chicken and lentil tagine with seasonal greens

Greek-style salad with feta and olives served alongside a vegetable omelette

Key ingredients include olive oil, fresh vegetables (capsicum, tomato, leafy greens), legumes (chickpeas, lentils), wholegrains (quinoa, brown rice), lean meats or fish, fresh herbs and citrus.

Anticipated Preparation and Cooking Time
Each meal is expected to take less than 30 minutes to prepare and cook, ensuring they are practical and accessible for people living with Parkinson’s disease and their families.

Batch Cooking
The meals provided in the meal box will not be batch-cooked. Instead, they will be designed for fresh preparation each day using pre-portioned ingredients. This approach supports flexibility in meal preparation and helps maintain food safety standards.

Advice for Remaining Main Meals
Participants will not receive specific guidance for the remaining meals outside of the provided meal box recipes. They will be able to choose what to cook or eat for their other main meals, whether that involves preparing different meals at home or eating out.

Preparation of Kitchen Safety Tips and Cooking Strategies
Kitchen safety tips and cooking strategies for the meal box will be developed by the occupational therapist on the research team. These resources will be tailored to the needs of people living with Parkinson’s disease, ensuring a safe and supportive cooking experience.

Intervention code [1]

Lifestyle

Comparator / control treatment

No comparator group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility

Assessment method [1]

Consistent with our recent work, the primary outcome of this research is the feasibility of the Mediterranean meal box intervention for people with Huntington's disease (pwHD) and their families. Feasibility is examined as a composite outcome. • Process: Feasibility will be assessed through participant recruitment and completion rates, including the number of participants referred, eligible and enrolled. Data will be captured from study enrolment, screening and withdrawal records. • Resources: Participant adherence, retention, and attrition rates will be monitored alongside communication needs between participants and staff, as well as the monetary costs of delivering the intervention. Study specific tracking logs will be used to record participant engagement with cooking the prescribed meals. Time spent conversing with participants and undertaking study specific activities will be recorded by staff with study-specific tracking logs. • Management: A realist approach to trial delivery will be evaluated by examining staff time required for recruitment, engagement and participant support. Time spent recruiting and engaging with study participants as well as providing support will be recorded with study-specific logs and databases. • Scientific: Adverse events, serious adverse events, and clinical emergencies will be documented. Participant experience will be evaluated via a short semi-structured interview at the conclusion of the study, focusing on barriers and motivators related to the meal box intervention, perceived positives and negatives. Interviews will also be used to capture adverse events (e.g., cut fingers, burns) along with participant study logs. These interviews will provide detailed insights into how the meal box aligns with participant needs and identify opportunities for refinement to enhance usability, acceptability and long-term sustainability.

Timepoint [1]

Feasibility will be examined throughout the duration of the study. Participant recruitment rates will be determined at the end of the study/following recruitment of the final eligible participant. Adverse events will be calculated following the completion 0f the intervention period and semi-structured interview. Interviews will be completed within two weeks of completing the intervention period.

Secondary outcome [1]

Cooking and eating behaviours evaluation

Timepoint [1]

Cooking and eating behaviours will be evaluated before and after the intervention period utilising a semi-structured interview.

Secondary outcome [2]

Quality of life

Timepoint [2]

Quality of life will be evaluated before and after the intervention period with the EQ-5D-L.

Eligibility

Key inclusion criteria

Forty HD families will be identified through existing research databases, Huntington's Australia and local clinicians and will be screened for study eligibility. Families will be required to have at least one member of the household with a neurologist-confirmed diagnosis of HD and experiencing symptoms of the disease. The person living with HD must be prepared and have the physical and cognitive capacity (clinician supported) to undertake cooking independently or with support throughout the duration of the intervention.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will include lack of access to functional food storage and cooking facilities within the home, the requirement for texture-modified foods due to later-stage HD and restrictive food allergies.

Study design

Purpose of the study

Treatment

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

Safety/efficacy

Statistical methods / analysis

Data analyses will be conducted using R software (version 4.3.0, 2023). Data normality will be assessed using the Shapiro–Wilks test, and parametric or nonparametric methods will be applied accordingly. Descriptive statistics, including percentages, means, and ranges, will summarise process, resource, and management feasibility outcomes. Safety, tolerability, and compliance measures will be evaluated throughout the study. Thematic analysis will be used to analyse data captured from semi-structured interviews.
Patient-reported QoL data will be analysed using the Friedman test. Significant differences will be further examined with post hoc pairwise comparisons using the Wilcoxon signed-rank test, with adjustments for multiple comparisons. Statistical significance will be set at p < .05. Qualitative data from semi-structured interviews will be analysed using thematic analysis.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

18/08/2025

Actual

Date of last participant enrolment

Anticipated

27/10/2025

Actual

Date of last data collection

Anticipated

3/11/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perpetual Limited

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Centre for Precision Health (Edith Cowan University)

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Edith Cowan University Human Research Ethics Committee

Ethics committee address [1]

http://www.ecu.edu.au/GPPS/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/05/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study aims to assess the feasibility of a mediterranean meal box for people living with Huntington's disease and their family. We hypothesise the meal box will be safe and feasible for this community. We also expect it to improve cooking behaviours and quality of life.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Travis Cruickshank

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia

Country

Australia

Phone

+61 08 6304 3416

Fax

[email protected]

Contact person for public queries

Name

Travis Cruickshank

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia

Country

Australia

Phone

+61 08 6304 3416

Fax

[email protected]

Contact person for scientific queries

Name

Travis Cruickshank

Address

Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Western Australia

Country

Australia

Phone

+61 08 6304 3416

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: The research is informing the development of a commercial product.

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.

Trial Review

Documents added manually

Documents added automatically