Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001284550
Ethics application status
Approved
Date submitted
1/10/2024
Date registered
22/10/2024
Date last updated
22/10/2024
Date data sharing statement initially provided
22/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the use of storytelling to promote appetite self-regulation in young children
Scientific title
Developing appetite self-regulation in New Zealand children: a pilot study to investigate the efficacy of a storytelling resource on persuasive feeding practices
Secondary ID [1] 313084 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 335327 0
eating behaviours 335328 0
Condition category
Condition code
Public Health 331898 331898 0 0
Other public health
Diet and Nutrition 331971 331971 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 20-minute online video, which introduced the 'Feeding with HEART' tool, was emailed to participants in the intervention group, The entire content of the intervention is delivered during the 20-minute online video. The video was designed to address negative parental feeding practices by using storytelling to surface values associated with responsive feeding practices, change parental beliefs about child appetite self-regulation using metaphor to increase understanding, create a positive emotional response using narrative, and then introduce the ‘Feeding with HEART’ roadmap, which included evidence-based positive feeding practices related to the development of child appetite self-regulation, which included the content from the initial pilot study

The ‘Feeding with HEART’ roadmap was designed to support children’s journey to becoming confident and healthy eaters. The H in HEART stands for ‘Helping’ and is about encouraging children to be involved in helping around meals. Practical suggestions for doing this were provided. The E stands for ‘Environment’, and involves removing distractions from the mealtime environment, such as screens, clutter, and overwhelming children with too much food on the plate. The A stands for ‘Ace’ and is borrowed from Katie Kimball’s ‘Kids Cook Real Food™’. This is about starting the meal with the food the caregiver most wants their child to eat or try. It is based on the principle that when we are hungry, food tastes better. The R stands for ‘Rules’, and this step introduced evidence-based guidelines for responsive feeding practices. Finally, the T in HEART stands for ‘Trust’. This is about the need for children to feel safe to eat and therefore the importance of strengthening the child-parent connection around mealtimes. A summary of the programme was provided at the end of the online course with details of the programme also emailed to parents so they could refer to it. We did not monitor adherence to the intervention.
Intervention code [1] 329642 0
Prevention
Intervention code [2] 329643 0
Behaviour
Comparator / control treatment
Participants randomised to the usual care group were asked to read a document from the New Zealand Heart Foundation. The information in the document was similar to that provided to the intervention group, but did not use the communication techniques that were used in the ‘Feeding with HEART’ tool, such as narrative and metaphor. At the end of the 1-month follow-up period, control participants were given access to the ‘Feeding with HEART’ tool.
Control group
Active

Outcomes
Primary outcome [1] 339515 0
Persuasive feeding
Timepoint [1] 339515 0
Baseline and 1-month follow-up.
Secondary outcome [1] 440270 0
Parental emotional responses during meals
Timepoint [1] 440270 0
Baseline and 1-month follow-up.
Secondary outcome [2] 440271 0
Parental feeding style
Timepoint [2] 440271 0
Baseline and 1-month follow-up.
Secondary outcome [3] 440272 0
Child responsiveness to food and eating
Timepoint [3] 440272 0
Baseline and 1-month follow-up.
Secondary outcome [4] 440497 0
Child responsiveness to feelings of fullness
Timepoint [4] 440497 0
Baseline and 1-month follow-up.

Eligibility
Key inclusion criteria
Parents or primary caregivers of children aged 3–6 years, aged at least 18 years who lived in New Zealand, had access to the internet, were able to provide electronic informed consent, and could speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents and caregivers of a child:
* With a significant developmental disorder, including autism
* With a significant eating issue
* Who struggles with a significant lack of interest in food
* Who avoids most foods because they could not tolerate the texture or consistency.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants were randomised in a 1:1 ratio within RedCap to the intervention or usual care groups. This was an automated process within the RedCap package.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This was a pilot trial and therefore was not powered to detect significant differences between groups in the primary outcome; however, the sample provides sufficient data to ascertain recruitment and the direction and likely effect size for outcomes. Baseline variables were summarised according to group and descriptive summary statistics provided. No significance testing was conducted on baseline measures as any differences between the groups at baseline could only have occurred by chance. Change from baseline to 1-month between the intervention and usual care groups were compared. The difference between groups in the binary outcomes were compared using Chi-squared tests. The distribution of continuous outcomes were assessed for normality. The change from baseline in the continuous outcomes was analysed using multiple linear regression modelling and adjusted for the baseline value. For non-normally distributed outcomes the median and inter-quartile range (IQR) data are presented, and the difference between groups were compared using the Wilcoxon two-sample test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/01/2023
Date of last participant enrolment
Anticipated
Actual
24/02/2023
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
112
Accrual to date
Final
94
Recruitment outside Australia
Country [1] 26594 0
New Zealand
State/province [1] 26594 0

Funding & Sponsors
Funding source category [1] 317529 0
Charities/Societies/Foundations
Name [1] 317529 0
New Zealand Heart Foundation
Country [1] 317529 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 319833 0
None
Name [1] 319833 0
Address [1] 319833 0
Country [1] 319833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316241 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 316241 0
Ethics committee country [1] 316241 0
New Zealand
Date submitted for ethics approval [1] 316241 0
08/09/2022
Approval date [1] 316241 0
13/10/2022
Ethics approval number [1] 316241 0

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

Contacts
Principal investigator
Name 137254 0
Dr Samantha Marsh
Address 137254 0
University of Auckland, School of Population Health, 22-30 Park Ave, Grafton, Auckland
Country 137254 0
New Zealand
Phone 137254 0
+64 21400904
Fax 137254 0
Email 137254 0
[email protected]
Contact person for public queries
Name 137255 0
Samantha Marsh
Address 137255 0
University of Auckland, School of Population Health, 22-30 Park Ave, Grafton, Auckland
Country 137255 0
New Zealand
Phone 137255 0
+64 21400904
Fax 137255 0
Email 137255 0
[email protected]
Contact person for scientific queries
Name 137256 0
Samantha Marsh
Address 137256 0
University of Auckland, School of Population Health, 22-30 Park Ave, Grafton, Auckland
Country 137256 0
New Zealand
Phone 137256 0
+64 21400904
Fax 137256 0
Email 137256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All requests for anonymous participant data or project documents will be considered.
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Researchers whose proposed use aligns with the ethical approval and participant consenting for the project, aligns with public good purposes, does not conflict with other requests, or planned use by the Project Steering Committee, and the requestor is willing to sign a data access agreement.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
[email protected]


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.