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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]

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

Condition category

Condition code

Neurological

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]

Lifestyle

Comparator / control treatment

No comparator

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 meal box intervention for person with Parkinson's disease (pwPD) and their families. Process: Feasibility will be assessed through participant recruitment and completion rates, including the number of participants referred, eligible and enrolled. 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. Management: A realist approach to trial delivery will be evaluated by examining staff time required for recruitment, engagement and participant support. 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. 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. Feasibility data is considered a composite outcome. Feasibility data will be collected using a combination of structured documentation and direct participant input: Process Data (Recruitment and Completion Rates): Research team members will record all participant recruitment, eligibility checks, enrolments, withdrawals and completions in a study-specific logbook. Resource Data (Participant Adherence, Retention and Support Needs): Study staff will maintain detailed logs documenting how many meal boxes were used as intended, any additional support provided to participants (e.g. phone or email troubleshooting) and any challenges participants faced while using the meal box. Management Data (Staff Time and Project Delivery): Staff time spent on participant support, delivery of the intervention and addressing issues will be documented in study-specific time logs. Scientific Data (Adverse Events and Safety): Participants will be asked to report any injuries sustained during the intervention period. They will be asked to report these promptly via email, noting the severity of the injury. These reports will be recorded in a study-specific adverse event log.

Timepoint [1]

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]

Cooking and eating behaviours evaluation

Timepoint [1]

Cooking and eating behaviours will be evaluated before and after the intervention period.

Secondary outcome [2]

Quality of life

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Parkinson's Western Australia

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]

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 evaluate the feasibility of a mediterranean meal box for people living with Parkinson's disease and their family. It is hypothesised that the meal box will be safe and practical for individuals with Parkinson's disease and their family to use. Furthermore, it is expected that it will promote healthy cooking and eating behaviours and better 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 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.

Trial Review

Documents added manually

Documents added automatically