Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001276347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/09/2026
Date registered
Help: Date registered
23/10/2026
Date last updated
Help: Date last updated
23/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility and acceptability of a whole foods diet on emotional dysregulation in children aged 7-11 years: a pilot study.
Scientific title
Investigating the feasibility and acceptability of a whole-foods diet as an intervention for emotional dysregulation in children aged 7–11 years: a pilot study.
Additional trial identifiers [1] 318204 0
Nil.
Universal Trial Number (UTN)
U1111-1345-4364
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Emotional Dysregulation 343261 0
Condition category
Condition code
Mental Health 339372 339372 0 0
Other mental health disorders
Public Health 339648 339648 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention?
This study will employ a one-arm, open-label, non-randomised, uncontrolled pilot design. All participants will undertake an 8-week, structured and progressive Whole Food Diet (WFD) intervention. The WFD is designed to gradually reduce exposure to ultra-processed foods (UPFs; e.g., packaged chips) while increasing the consumption and variety of minimally processed and whole foods (e.g., fruits and vegetables).

UPFs will be defined according to the NOVA classification system, which categorises foods into four groups (NOVA 1 to 4) based on the nature, extent, and purpose of food processing, rather than nutritional composition alone (Louie, 2025). The intervention will focus on progressively reducing consumption of NOVA 4 foods, which include ultra-processed products such as packaged snacks, sugar-sweetened beverages, instant noodles, and some ready-to-eat meals (Huybrechts et al., 2022). Importantly, the intervention will emphasise gradual substitution rather than strict restriction, with families supported to identify achievable dietary changes that increase access to nutritious, minimally processed alternatives.

The intervention will be family/whanau-centred and supported by dietary education, individualised dietary goals, ongoing guidance, and a purpose-built smartphone application, Pantry. Pantry will support food literacy and increase awareness of UPFs through features including barcode scanning, meal logging, meal planning, and recipe provision. These components are intended to support families to translate the dietary principles into practical, sustainable changes within their everyday home environment.


Who delivers it and their relevant expertise?
The intervention will be coordinated and primarily delivered by a psychology postgraduate student within Te Puna Toiora: Mental Health and Nutrition Research Laboratory at the University of Canterbury. The student will coordinate study procedures, deliver the dietary education, support families to establish and review individualised dietary goals, provide ongoing support, and conduct participant interviews and assessments. The study’s Principal Investigator and supervising researcher is a Registered Clinical Psychologist and Professor at the University of Canterbury, with expertise in food and mental health.

A Registered Dietitian will provide nutritional guidance and professional oversight to the psychology student throughout the intervention. This guidance will support the development of nutritionally appropriate dietary goals and help identify practical ways to implement dietary changes while meeting children's age-appropriate nutritional requirements.

A Registered Psychiatrist will provide clinical oversight throughout the study, while a cultural advisor will offer guidance to support culturally appropriate delivery of the intervention. A PhD candidate from Te Puna Toiora: Mental Health and Nutrition Research Laboratory will serve as a co-investigator, providing support across study procedures. A second PhD candidate from the same laboratory will also serve as a co-investigator and is responsible for the development and technical support of the Pantry application.


How it is delivered (e.g. face to face, online, group, individual)?
The intervention will be delivered individually via Zoom to each child and their parent/legal guardian. Families will implement dietary changes within their usual home and community environments, supported by the Pantry application and ongoing contact with the study’s coordinator.
The intervention will commence once the baseline questionnaire, a baseline meeting, and two days (one weekday and one weekend day) of baseline food diaries have been completed. During the baseline meeting, the study coordinator will administer baseline assessments, including the PTP and CLAR-I, provide dietary education and training in the Pantry application, and collaboratively establish initial dietary goals.
Dietary education will include an overview of relevant research exploring the relationship between ultra-processed food (UPF) consumption and mental health. Parents will be introduced to the NOVA classification system, with particular emphasis on identifying Group 4 UPFs and distinguishing these from foods in Groups 1 to 3. Practical examples, such as packaged snacks, will be used to help parents recognise common UPFs in their child’s diet.
Education will also explore the potential nutritional differences between UPFs and whole or minimally processed foods, including how diets high in UPFs may displace foods that provide essential nutrients. The intervention will emphasise gradual and realistic dietary changes rather than an elimination-based approach. Care will be taken to avoid demonising particular foods or labelling them as “good” or “bad”. Instead, the education will promote an understanding of how foods differ in their degree of processing and nutritional contribution, supporting families to make informed, balanced dietary choices without creating unnecessary guilt or stigma around food.
During the baseline meeting, the coordinator will assist parents with downloading and setting up the Pantry application and provide guidance on how to use relevant application features. Additionally, initial dietary goals will be established collaboratively using information from the baseline questionnaire, including the EAT-5, alongside the coordinator’s discussion with the parent/ guardian about the child’s food preferences, existing dietary patterns and barriers to change. From there, two to three achievable initial goals will be agreed upon.
Throughout the eight-week intervention, parents/ guardians will complete questionnaires every two weeks. Families will also be asked to record all food and drink consumed by the child in the Pantry application on two days during the intervention, comprising one weekday and one weekend day.
Parents/ guardians will also meet with the study coordinator at weeks four and eight. These meetings will provide an opportunity to review dietary progress, discuss challenges, revisit existing goals and administer the PTP and CLAR-I. The final meeting at week eight will provide an opportunity to review progress across the intervention and discuss the family’s experience of implementing the dietary changes.
Dietary goals will be reviewed, adjusted, or updated as needed, with the study coordinator maintaining contact with parents/guardians throughout the intervention to provide on-going support. This flexible approach will allow the intervention to be tailored to each family while maintaining its overall focus on reducing UPFs and increasing whole and minimally processed foods.

How often and for how long (e.g. 8 x 1-hour sessions over 8 weeks)?
The intervention will run for eight weeks, commencing once all baseline assessments have been completed. Participant involvement will include one baseline meeting, two follow-up meetings, fortnightly questionnaires, and fortnightly food and drink logging.

The baseline phase will involve completing a questionnaire, estimated to take 40–50 minutes, and recording the child’s food and drink intake over two full days, comprising one weekday and one weekend day. Participants will also attend one 1-hour baseline meeting via Zoom.

Throughout the eight-week intervention, parents or legal guardians will complete questionnaires every two weeks, each estimated to take 10–15 minutes and record the child’s food and drink intake over two full days (one weekday and one weekend day) every two weeks. Follow-up meetings will occur at weeks four and eight, each lasting approximately one hour. This will result in three 1-hour meetings in total, including the baseline meeting.

At the conclusion of the eight-week intervention, participants will complete a final post-intervention questionnaire, estimated to take 40–50 minutes. In addition to these scheduled activities, the study coordinator will provide ongoing support and check-ins throughout the intervention as needed to assist families with implementing dietary changes.

Where it is delivered (e.g. clinic, participant's home, school)?
All intervention sessions are delivered via Zoom while dietary changes will be implemented by families within their usual home and community environment, with support provided throughout from the study team and by the Pantry application. Parents/ guardians will also be able to contact the coordinator via email or phone to receive on-going support.

Adherence (e.g. reminders, monitoring)?
Adherence is supported through individualised and achievable dietary goals, fortnightly monitoring, regular contact, dietary education, Pantry engagement, food photographs and dietary records. Families will receive practical resources and a $40 supermarket voucher every two weeks to reduce practical barriers. Adherence will be monitored through drop-out rates, dietary records, food photographs, Pantry data, as well as goal, questionnaire and interview completion. Barriers to adherence will be discussed during follow-up contacts, and goals can be modified to remain feasible and appropriate for the family.
Intervention code [1] 335102 0
Lifestyle
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346660 0
Feasibility
Timepoint [1] 346660 0
Baseline, Weeks 1, 2, 3, 4, 5, 6, and 8 (end of intervention).
Primary outcome [2] 346964 0
Feasibility
Timepoint [2] 346964 0
Baseline, Weeks 1, 2, 3, 4, 5, 6, and 8 (end of intervention).
Primary outcome [3] 347176 0
Feasibility
Timepoint [3] 347176 0
Baseline, Weeks 1, 2, 3, 4, 5, 6, and 8 (end of intervention).
Secondary outcome [1] 466928 0
Emotional dysregulation
Timepoint [1] 466928 0
Baseline, Weeks 2, 4, 6, and 8 (end of intervention).
Secondary outcome [2] 467840 0
Disruptive mood dysregulation disorder
Timepoint [2] 467840 0
Baseline and week 8 (end of intervention)
Secondary outcome [3] 467841 0
Child Depression
Timepoint [3] 467841 0
Baseline and week 8 (end of intervention)
Secondary outcome [4] 467842 0
Parental Depression
Timepoint [4] 467842 0
Baseline and week 8 (end of intervention).
Secondary outcome [5] 467843 0
Parental Stress
Timepoint [5] 467843 0
Baseline and week 8 (end of intervention).
Secondary outcome [6] 467844 0
Oppositional defiant disorder
Timepoint [6] 467844 0
Baseline and week 8 (end of intervention)
Secondary outcome [7] 467845 0
Iritability
Timepoint [7] 467845 0
Baseline, weeks 2, 4, 6, and 8 (end of intervention)
Secondary outcome [8] 467846 0
Emotional outbursts
Timepoint [8] 467846 0
Baseline, weeks 2, 4, 6, and 8 (end of intervention)
Secondary outcome [9] 467856 0
Attention deficit hyperactivity disorder
Timepoint [9] 467856 0
Baseline and week 8 (end of intervention).
Secondary outcome [10] 467858 0
Autism Spectrum Disorder
Timepoint [10] 467858 0
Baseline and week 8 (end of intervention).
Secondary outcome [11] 467862 0
Behavioural Outcomes
Timepoint [11] 467862 0
Baseline and weeks 2, 4, and 8 (end of intervention).
Secondary outcome [12] 467865 0
Diet Patterns
Timepoint [12] 467865 0
Baseline, weeks 2, 4, 6, and 8 (end of intervention).
Secondary outcome [13] 467867 0
Gastrointestinal Symptoms
Timepoint [13] 467867 0
Baseline and week 8 (end of intervention).
Secondary outcome [14] 467869 0
Child Anxiety
Timepoint [14] 467869 0
Baseline, weeks 2, 4, 6, and 8 (end of intervention).
Secondary outcome [15] 467870 0
Parental Anxiety
Timepoint [15] 467870 0
Baseline and week 8 (end of intervention).
Secondary outcome [16] 467871 0
Parental Stress
Timepoint [16] 467871 0
Baseline and week 8 (end of intervention).
Secondary outcome [17] 467872 0
Stress in relation to parenting
Timepoint [17] 467872 0
Baseline and week 8 (end of intervention).
Secondary outcome [18] 467873 0
Adverse Effects
Timepoint [18] 467873 0
Baseline, week 2, 4, 6 and 8 (end of intervention).
Secondary outcome [19] 467874 0
Ultra-processed food consumption
Timepoint [19] 467874 0
Baseline, week 2, 4, 6 and 8 (end of intervention).
Secondary outcome [20] 467875 0
General functioning
Timepoint [20] 467875 0
Baseline, weeks 4 and 8 (end of intervention).
Secondary outcome [21] 467876 0
Global improvement
Timepoint [21] 467876 0
Baseline, weeks 4 and 8 (end of intervention).
Secondary outcome [22] 467877 0
Parental: Main Concern in Regards to their Child
Timepoint [22] 467877 0
Baseline, weeks 4 and 8 (end of intervention).
Secondary outcome [23] 467878 0
Irritability
Timepoint [23] 467878 0
Baseline, weeks 4 and 8 (end of intervention).
Secondary outcome [24] 467879 0
Self Efficacy
Timepoint [24] 467879 0
Baseline, weeks 2, 4, 6 and 8 (end of intervention).
Secondary outcome [25] 469341 0
Acceptability - This is a primary outcome.
Timepoint [25] 469341 0
Baseline and weeks 2, 4, 6 and 8 (end of intervention)
Secondary outcome [26] 469342 0
Acceptability - This is a primary outcome.
Timepoint [26] 469342 0
Baseline and weeks 2, 4, 6 and 8 (end of intervention)
Secondary outcome [27] 469343 0
Acceptability - This is a primary outcome.
Timepoint [27] 469343 0
Baseline and weeks 2, 4, 6 and 8 (end of intervention)

Eligibility
Key inclusion criteria
1. Eligible children will score greater than or equal to 10 on the Emotion Dysregulation Inventory Reactivity subscale, greater than or equal to 1 on the Affective Reactivity Index, and be rated at least moderately impaired on the CGI-Severity scale.
2. Must be aged between 7 and 11 years of age,
3. Participants must have English competency sufficient to interpret and complete study materials and questionnaires correctly,
4. Must be medication-free (psychiatric) for more than 4 weeks,
5. Participants must be open/willing and able to make dietary changes in accordance with the Whole Food Diet intervention,
6. Have at least one parent/legal guardian who is comfortable using online video technology (e.g., Zoom) and can participate in the required sessions, either in person or via Zoom, throughout the 8-week programme. The same parent, caregiver, or whanau member must participate throughout the 8 week programme.
Minimum age
7 Years
Maximum age
11 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Any serious medical or psychiatric condition potentially requiring hospitalisation.
2. Presence of a diagnosed eating disorder, significant disordered eating behaviours, or dietary restrictions that would prevent safe or meaningful participation in the Whole Food Diet intervention.
3. Any serious mental health or behavioural concerns for either parent or child that may interrupt their ability to engage or compromise participation (e.g., severe conduct disorder, intellectual disability).
4. Have multiple food allergies that significantly restrict dietary options and may impair the participant’s ability to adhere to the dietary intervention, potentially resulting in inadequate food intake or nutritional deficiencies.

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
Statistical methods / analysis
The proposed sample of approximately 20 participants is intended to provide sufficient information regarding recruitment, retention, assessment completion, intervention adherence, acceptability, participant burden and practical delivery of the intervention. The sample is not intended to provide adequate statistical power to establish definitive clinical efficacy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 28465 0
New Zealand
State/province [1] 28465 0

Funding & Sponsors
Funding source category [1] 322768 0
University
Name [1] 322768 0
The University of Canterbury
Country [1] 322768 0
New Zealand
Primary sponsor type
Individual
Name
Professor Julia Rucklidge, The University of Canterbury
Address
Country
New Zealand
Secondary sponsor category [1] 325690 0
Individual
Name [1] 325690 0
Olivia Lonsdale, The University of Canterbury
Address [1] 325690 0
Country [1] 325690 0
New Zealand
Secondary sponsor category [2] 325931 0
Individual
Name [2] 325931 0
Alix Harding, The University of Canterbury
Address [2] 325931 0
Country [2] 325931 0
New Zealand
Secondary sponsor category [3] 325932 0
Individual
Name [3] 325932 0
Isabella Garbett, The University of Canterbury
Address [3] 325932 0
Country [3] 325932 0
New Zealand
Secondary sponsor category [4] 325933 0
Individual
Name [4] 325933 0
Dr. Stephanie Brown, The University of Otago
Address [4] 325933 0
Country [4] 325933 0
New Zealand
Secondary sponsor category [5] 325934 0
Individual
Name [5] 325934 0
Dr. Kat Donovan, The University of Otago
Address [5] 325934 0
Country [5] 325934 0
New Zealand
Secondary sponsor category [6] 325935 0
Individual
Name [6] 325935 0
Taryn Hale (Ngati Koara), The University of Canterbury
Address [6] 325935 0
Country [6] 325935 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321206 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 321206 0
Ethics committee country [1] 321206 0
New Zealand
Date submitted for ethics approval [1] 321206 0
20/08/2026
Approval date [1] 321206 0
08/09/2026
Ethics approval number [1] 321206 0

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

Contacts
Principal investigator
Name 153014 0
Prof Julia Rucklidge
Address 153014 0
Te Puna Toiora: Mental Health and Nutrition Laboratory; Room 465 School of Psychology, Speech and Hearing University of Canterbury Private Bag 4800, Christchurch, 8140, New Zealand
Country 153014 0
New Zealand
Phone 153014 0
+64 3 369 4398
Fax 153014 0
Email 153014 0
[email protected]
Contact person for public queries
Name 153015 0
Julia Rucklidge
Address 153015 0
Te Puna Toiora: Mental Health and Nutrition Laboratory; Room 465 School of Psychology, Speech and Hearing University of Canterbury Private Bag 4800, Christchurch, 8140, New Zealand
Country 153015 0
New Zealand
Phone 153015 0
+64 3 369 4398
Fax 153015 0
Email 153015 0
[email protected]
Contact person for scientific queries
Name 153016 0
Julia Rucklidge
Address 153016 0
Te Puna Toiora: Mental Health and Nutrition Laboratory; Room 465 School of Psychology, Speech and Hearing University of Canterbury Private Bag 4800, Christchurch, 8140, New Zealand
Country 153016 0
New Zealand
Phone 153016 0
+64 3 369 4398
Fax 153016 0
Email 153016 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
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes 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:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• [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.