ANZCTR - Registration

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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

13/08/2024

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Brain Bites

Linked study record

Health condition

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

Neurological condition

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Neurological

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]

Behaviour

Intervention code [2]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Process, resource, management and scientific feasibility assessed as a composite outcome

Assessment method [1]

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]

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]

Change in the mealtime-related impact on quality of life in people living with early-stage Huntington's Disease and their family members.

Timepoint [1]

Pre and Post trial

Secondary outcome [2]

Change in nutritional intake

Timepoint [2]

Pre and Post trial

Secondary outcome [3]

Change in the mealtime-related impact on activities of daily living in people living with early-stage Huntington's Disease and their family members.

Timepoint [3]

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?

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

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]

05/04/2024

Approval date [1]

01/05/2024

Ethics approval number [1]

REMS No: 2023-04908-REES

Summary

Brief summary

Nutritional challenges due to motor, cognitive and swallowing issues, arise in Huntington's Disease (HD), leading to malnutrition and reduced quality of life (QoL). We aim to evaluate a co-designed meal-box solution for improving nutrition and QoL in HD. Fifteen HD families will receive the meal-box comprising recipes and ingredients for five meals. Feasibility, acceptability, QoL and nutritional intake will be assessed pre and post, using qualitative and quantitative measures. Positive results could lead to rapid implementation within the HD community through our industry partner, with potential to extend the novel approach to other neurological conditions, thereby addressing a critical need.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Joanna Rees

Address

Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027

Country

Australia

Phone

+61 0403872227

Fax

j.rees@ecu.edu.au

Contact person for public queries

Name

Joanna Rees

Address

Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027

Country

Australia

Phone

+61 0403872227

Fax

j.rees@ecu.edu.au

Contact person for scientific queries

Name

Joanna Rees

Address

Edith Cowan University, School of Medical and Health Sciences, 270 Joondalup Drive, Joondalup, Western Australia 6027

Country

Australia

Phone

+61 0403872227

Fax

j.rees@ecu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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