Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000477426p
Ethics application status
Submitted, not yet approved
Date submitted
1/05/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Empowering caregivers: Building parent/caregivers’ confidence in managing childhood picky eating
Scientific title
An intervention measuring the confidence levels of parents'/caregivers' managing of childhood picky eating, pre and post a set of online group workshops
Secondary ID [1] 314181 0
Nil known
Universal Trial Number (UTN)
U1111-1321-4634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregiver stress 337041 0
Condition category
Condition code
Mental Health 333488 333488 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 333823 333823 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical information/material – worksheets provided to participants (designed specifically for the study.
Delivery format – live video conference group workshops
Participant tasks – participants will have practice activities between workshops they may action, should they wish, with the opportunity for support/troubleshooting feedback
Delivery – lead researcher, nutritional therapist, 10 years experience as picky eating advisor, PhD candidate psychology. MSc psychology.
Mode of delivery – group via video conference over internet
Duration – 5 group workshops of approx. 1 hour each, once per week for 5 weeks.
Location – participants can join from any location in New Zealand with internet access
Personalising – there will be the opportunity to adapt certain parts of the workshops to suit individuals/groups of participants eg. to speak to issues specific to sensory sensitivities, if that is relevant to participants. Participants will discuss their challenges in their pre-intervention interviews and flexibility will be built into the workshops and delivery to speak to these. Participants will also be able to speak directly to the researcher at the end of each workshop if there are specific questions or challenges.
Adherence – there will be emphasis on the importance of attending all 5 group workshops. Attendance at workshops will be noted.
After the study – caregivers will have access to resources from the study and use those to support ongoing confidence around mealtimes.
Intervention code [1] 330863 0
Behaviour
Intervention code [2] 331043 0
Lifestyle
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341069 0
Primary outcome: Confidence expressed by participants to manage mealtimes, food and feeding for their picky eater (mealtimes/food/feeding compositely)
Timepoint [1] 341069 0
Timepoints: At times convenient to participants, within 2 weeks prior to first intervention workshop and within 2 weeks of completing the final intervention workshop.
Secondary outcome [1] 446040 0
Secondary outcome: Gauge the effectiveness of the workshops and iterative changes that need to be made through using post workshop feedback questionnaires from participants.
Timepoint [1] 446040 0
Timepoints: Semi-structured interviews within 2 weeks of completing the final workshop. Questionnaires returned after each workshop.

Eligibility
Key inclusion criteria
Caregivers of children who are picky eaters aged 4-7 years old
Caregivers where children’s picky eating is characterised by both a limited diet and problematic feeding behaviours and has been an issue for 6 months or more.
Caregivers of all genders, ability, age or from any cultural community are welcome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not fluent in spoken English – as data collection and the intervention will be delivered in English
Those without access to a computer/smart phone or reliable wi-fi as the intervention will be conducted online.
Caregivers of children with high medical needs requiring medical monitoring
Caregivers with shared custody arrangements where only one caregiver wishes to participate (as the intervention will likely not be effective)

Study design
Purpose of the study
Educational / counselling / training
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
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
1/07/2025
Actual
Date of last participant enrolment
Anticipated
29/07/2025
Actual
Date of last data collection
Anticipated
10/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26960 0
New Zealand
State/province [1] 26960 0

Funding & Sponsors
Funding source category [1] 318697 0
University
Name [1] 318697 0
Massey University
Country [1] 318697 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 321130 0
None
Name [1] 321130 0
Address [1] 321130 0
Country [1] 321130 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317306 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317306 0
Ethics committee country [1] 317306 0
New Zealand
Date submitted for ethics approval [1] 317306 0
08/05/2025
Approval date [1] 317306 0
Ethics approval number [1] 317306 0

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

Contacts
Principal investigator
Name 140638 0
Mrs Judith Yeabsley
Address 140638 0
Massey University, PO Box 756 Wellington 6140 New Zealand
Country 140638 0
New Zealand
Phone 140638 0
+64 277319402
Fax 140638 0
Email 140638 0
[email protected]
Contact person for public queries
Name 140639 0
Judith Yeabsley
Address 140639 0
Massey University, PO Box 756 Wellington 6140 New Zealand
Country 140639 0
New Zealand
Phone 140639 0
+64 277319402
Fax 140639 0
Email 140639 0
[email protected]
Contact person for scientific queries
Name 140640 0
Judith Yeabsley
Address 140640 0
Massey University, PO Box 756 Wellington 6140 New Zealand
Country 140640 0
New Zealand
Phone 140640 0
+64 277319402
Fax 140640 0
Email 140640 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• Participants will be able to access their interview data
Academic journals and other researchers can request access to deindentified data with approval from lead researcher

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee

• Participants will only be able to access their own data

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
For participants after end of post-intervention interview. For others by request.

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.