Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:30pm (AEST) on Thursday 31st July for website maintenance.

Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

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
ACTRN12625000607471p
Ethics application status
Submitted, not yet approved
Date submitted
26/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain Bites Parkinson's Disease: A co-designed meal box solution
Scientific title
Evaluating the feasibility of a co-designed meal box solution for people living with Parkinson’s disease
Secondary ID [1] 314532 0
None
Universal Trial Number (UTN)
U1111-1323-3283
Trial acronym
Brain Bites PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 337632 0
Condition category
Condition code
Neurological 333958 333958 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Mediterranean meal box intervention will be provided to individuals with symptomatic Parkinson’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 per week, for a total of eight meals over two weeks. Boxes will also include kitchen safety tips and cooking strategies tailored to the needs of people living with Parkinson’s disease. Participants will be asked to prepare the meals during the two-week period 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] 331163 0
Lifestyle
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341609 0
Feasibility
Timepoint [1] 341609 0
Feasibility will be evaluated throughout the entirety of the study. Recruitment rates will be determined following the enrolment of the last participant into the study. Adverse events will be calculated following the intervention period and post the semi-structured interview. Interviews will be undertaken with participants two-weeks following completion of the intervention period.
Secondary outcome [1] 448066 0
Cooking and eating behaviours evaluation
Timepoint [1] 448066 0
Cooking and eating behaviours will be evaluated before and after the intervention period.
Secondary outcome [2] 448067 0
Quality of life
Timepoint [2] 448067 0
Quality of life will be evaluated before and after the intervention period.

Eligibility
Key inclusion criteria
Twenty pwPD and their family members will be identified via existing PD databases, Parkinson’s WA and local clinicians and screened for eligibility. Inclusion criteria for pwPD include an established diagnosis of PD, being drug naive or on a stable medication regimen, Hoehn & Yahr stage equal to 3 in the clinical ‘ON’ state and willingness and capacity to engage in the intervention (e.g. ability to cook with or without support).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for pwPD include diagnosed dysphagia and severe cognitive or movement disturbances preventing participation (Tele-MoCA score <17 and UPDRS-Motor score <36). Family members must live in the same household as the pwPD or provide regular support, be willing to engage in the intervention (e.g. assisting with meal preparation or consumption) and be aged 18 years or older. Family members will be excluded if they have health conditions that prevent participation in study procedures or if they are unwilling to engage. This eligibility criteria ensures the inclusion of pwPD and family members who can meaningfully engage in and benefit from the intervention.

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
Since this was a feasibility study no sample size calculation was performed. This is in accordance with current recommendations from CONSORT (Eldridge et al 2016). Based on our previous trials on meal box solutions, twenty pwPD was deemed sufficient to test the feasibility of the meal box and explore the preliminary effects on cooking behaviours, nutritional intake and quality of life.

Statistical 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 across study phases (pre-intervention, intervention, post-intervention). Thematic analysis will be used to analyse data captured from semi-structured interviews. Patient-reported quality of life 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 conducted 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
20/10/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 319082 0
Charities/Societies/Foundations
Name [1] 319082 0
Parkinson's Western Australia
Country [1] 319082 0
Australia
Primary sponsor type
University
Name
Centre for Precision Health (Edith Cowan University)
Address
Country
Australia
Secondary sponsor category [1] 321543 0
None
Name [1] 321543 0
Address [1] 321543 0
Country [1] 321543 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317679 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317679 0
Ethics committee country [1] 317679 0
Australia
Date submitted for ethics approval [1] 317679 0
23/05/2025
Approval date [1] 317679 0
Ethics approval number [1] 317679 0

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

Contacts
Principal investigator
Name 141794 0
Dr Travis Cruickshank
Address 141794 0
Edith Cowan University, 270 Joondalup Drive Joondalup, 6027, Western Australia
Country 141794 0
Australia
Phone 141794 0
+61 08 6304 3416
Fax 141794 0
Email 141794 0
[email protected]
Contact person for public queries
Name 141795 0
Travis Cruickshank
Address 141795 0
Edith Cowan University, 270 Joondalup Drive Joondalup, 6027, Western Australia
Country 141795 0
Australia
Phone 141795 0
+61 08 6304 3416
Fax 141795 0
Email 141795 0
[email protected]
Contact person for scientific queries
Name 141796 0
Travis Cruickshank
Address 141796 0
Edith Cowan University, 270 Joondalup Drive Joondalup, 6027, Western Australia
Country 141796 0
Australia
Phone 141796 0
+61 08 6304 3416
Fax 141796 0
Email 141796 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The research captured from this study is being used to develop 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.