Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000533695
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
19/05/2023
Date last updated
4/09/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feel Good Study: Studying the relationship between fruits, vegetables, and children’s mental well-being.
Scientific title
Effects of increased fruit and vegetable intake on children’s mental and cognitive health: A pilot/feasibility study.
Secondary ID [1] 309570 0
None
Universal Trial Number (UTN)
U1111-1292-0223
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 329872 0
Cognitive Health 329873 0
Condition category
Condition code
Mental Health 326778 326778 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 326779 326779 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a cluster randomised controlled trial amongst primary school students in school years 4-6 (ages 8-11), which has one intervention arm and one control arm (habitual diet).

The intervention is a multi-component approach that focuses on increasing fruit and vegetable intake in children over a 10-week period in the school term. The intervention has been designed using behaviour change science, and the Behaviour Change Wheel is the theoretical framework underpinning the intervention. The multi-component intervention addresses key determinants of fruit and vegetable intake in children (availability/access, acceptance), and has the ambition to not only increase fruit and vegetable intake during the intervention, but to promote longer-lasting behaviour change beyond this trial alone.

The 10-week programme is delivered in both the school and home setting and includes a weekly fruit box delivery to schools, a weekly vegetable box delivery to homes, sensory experiential learning at school which focuses on increasing acceptance of fruits and vegetables, and a home-based support package which includes recipes, preparation tips/tricks, and a study Facebook group to encourage engagement from the families of participating children. The food provision means that participants will have the opportunity to increase their fruit and vegetable intake by 1 serve each per day.

The sensory experiential learning programme includes 6x 30 minute lessons, with the intention to deliver once a fortnight during the intervention though this can be adapted to school's preferences. This is a classroom-based programme, Successful elements from previous sensory experiential learning have been integrated into school lesson plans, using the Flavour School programme and Sapere method as a guide. The lessons have been developed and will be delivered by Registered Dietitians with at least 5y experience using the teaching manual. The aim is to positively prime children to eat fruits and vegetables by increasing their acceptance, and is based on a scientific framework of food preference development. Each lesson will be based on a different sense, and include worksheet activities, hands on learning, and opportunity to taste different fruits and vegetables. Contingent reinforcement will be achieved through role modelling, rewards (e.g., stickers) and activities incorporated both in the sensory lessons and home-based support package.

The home-based support package is designed to reinforce children's learning at school, and provide longer-lasting benefits for families. Given that families will be receiving vegetable boxes, the home-based support package will be primarily focused on vegetable intake and acceptance. Components include recipes (using existing resources from reputable organisations, e.g., Heart Foundation, Love Food Hate Waste, or 5+ a day), preparation tips/tricks (e.g., maximizing preferred sensory qualities of vegetables), information around role modelling (e.g., importance of promoting vegetables as fun and tasty, not just for health). There will also be a study Facebook group which will be monitored by the research dietitians and include a weekly photo challenge, and videos/posts for inspiration (e.g., recipes, photos from class lessons). It is at participant’s discretion how much time they spend interacting with the different components of the home-based support package. The home-based support package components will be provided to participants in several mediums including hard copies with the vegetable box delivery (recipes), through the private study Facebook group, and in a weekly newsletter sent via email.

Intervention adherence will be measured by changes in children's fruit and vegetable intake from baseline to the 10-week follow-up (collected through child- and parent-reported questionnaires on dietary intake). There is no specified serve size to compare adherence to for this pilot/feasibility study, and it is expected that this pilot/feasibility study will help define the required increase in fruit/vegetable intake for measuring adherence in a larger randomised controlled trial.

Intervention fidelity will be measured in the process evaluation of this study. Components will include the number of interactive sessions delivered and whether the lesson objectives were met in each lesson, whether fruit boxes were delivered to schools as planned, whether vegetable boxes were delivered to home as planned, and what resources of the home-based support package parents/caregivers utilised. The process evaluation includes questionnaires/interviews completed by teachers, parents/caregivers, and children.

Intervention code [1] 325994 0
Lifestyle
Intervention code [2] 325995 0
Behaviour
Comparator / control treatment
The comparator is habitual dietary intake. This is a wait-list control, which will receive a simplified version of the fruit and vegetable intervention after the final data set has been collected. The simplified intervention will run for a shorter duration (5 weeks), and include a consolidated version of the sensory experiential learning programme at schools (1 lesson), weekly fruit and vegetable boxes delivered to families at home for 5 weeks, and access to the full set of resources in the home-based support package.
Control group
Active

Outcomes
Primary outcome [1] 334635 0
Feasibility of the Feel Good study, including participant recruitment (defined as number of participants that consented to participate from those who are eligible and were invited to participate). This data will be sourced from information provided by teachers (number of children in the classroom) and an audit of study screening and enrolment logs.
Timepoint [1] 334635 0
Cumulative data will be assessed at Week 10 (end of intervention).
Primary outcome [2] 334636 0
Feasibility of the Feel Good study, including participant retention (defined as percentage of enrolled participants that completed data collection at baseline and the 10-week follow-up). This data will be sourced from an audit of the study REDCap database which includes study enrolment, withdrawal, and loss to follow-up logs.
Timepoint [2] 334636 0
Cumulative data will be assessed at Week 10 (end of intervention)
Secondary outcome [1] 421471 0
Feasibility of the Feel Good study, including successful collection and completion of biological samples (stool samples which are an optional component of the study, with a target of 80% completed from those who consent to participate). This data will be sourced from an audit of the study REDCap database.
Timepoint [1] 421471 0
Cumulative data will be assessed at Week 10 (end of intervention)
Secondary outcome [2] 421472 0
Feasibility of the Feel Good study, including successful collection and analysis of mental well-being questionnaires and cognitive assessments (with a target of 80%). This data will be sourced from an audit of the study REDCap database.
Timepoint [2] 421472 0
Cumulative data will be assessed at Week 10 (end of intervention)
Secondary outcome [3] 421473 0
Feasibility of the Feel Good study, including intervention implementation rate (defined as the extent to which intervention items were used as intended by the audience). This will be measured by questionnaires completed by teachers and parents/caregivers, where participants respond Yes/No for whether they had received that intervention component, and whether it had been implemented. These questionnaires have been designed specifically for this study.
Timepoint [3] 421473 0
Cumulative data will be assessed at Week 10 (end of intervention)
Secondary outcome [4] 421474 0
Changes to fruit and vegetable intake from baseline to the 10-week follow-up. This will reported as serves/day by the parent, and measured by the DICE (Dietary Index for a Child's Eating) questionnaire.
Timepoint [4] 421474 0
Baseline and Week 10 (end of intervention)
Secondary outcome [5] 421475 0
Skin carotenoid concentrations (a proxy for fruit and vegetable intake), reported as mean concentrations. This will be measured by the "Veggie Meter", a spectroscopy-based carotenoid measurement.
Timepoint [5] 421475 0
Baseline and Week 10 (end of intervention)
Secondary outcome [6] 421476 0
Children's nutrition behaviours specifically related to fruits and vegetables, including fruit and vegetable knowledge. This will be measured by a questionnaire asking children if they have tried 15 commonly consumed fruits/vegetables before, and reported as percentage of children responding yes or no. (Questionnaire has been created specifically for this study).
Timepoint [6] 421476 0
Baseline and Week 10 (end of intervention)
Secondary outcome [7] 421477 0
Children's nutrition behaviours specifically related to fruits and vegetables, including fruit and vegetable acceptance. This will be measured by a 5-point hedonic facial scale which asks children to rate their acceptance of 15 commonly consumed fruits and vegetables, and reported as mean scores. (Adapted from Poelman et al(2020) for the New Zealand context).
Timepoint [7] 421477 0
Baseline and Week 10 (end of intervention)
Secondary outcome [8] 421478 0
Children's nutrition behaviours specifically related to fruits and vegetables, including willingness to try new fruits and vegetables. This will be measured by a questionnaire asking children if they are willing to try 15 fruits and vegetables (if they have not already tried this before). This will be reported as a percentage of children responding yes or no. (Adapted from Pelman et al (2020) for the New Zealand context).
Timepoint [8] 421478 0
Baseline and Week 10 (end of intervention)
Secondary outcome [9] 421479 0
Children's nutrition behaviours, including food fussiness. This will be measured by the Fussiness subscale of the Child Eating Behaviour Questionnaire completed by parents/caregivers, and reported as mean scores.
Timepoint [9] 421479 0
Baseline and Week 10 (end of intervention)
Secondary outcome [10] 421480 0
Children's nutrition behaviours, including food neophobia. This will be measured by the Food Neophobia Scale completed by parents/caregivers, and reported as mean scores.
Timepoint [10] 421480 0
Baseline and Week 10 (end of intervention)
Secondary outcome [11] 421481 0
Children's diet quality. This will be measured by the Dietary Index for a Child's Eating (DICE) questionnaire completed by parents/caregivers, and reported as mean scores.
Timepoint [11] 421481 0
Baseline and Week 10 (end of intervention)
Secondary outcome [12] 421482 0
Children's mental health. This will be measured by the Strengths and Difficulties questionnaire completed by parents/caregivers, and reported as mean scores.
Timepoint [12] 421482 0
Baseline and Week 10 (end of intervention)
Secondary outcome [13] 421483 0
Children's cognitive performance. This will be measured by the NIH toolbox completed by children, and reported as mean scores.
Timepoint [13] 421483 0
Baseline and Week 10 (end of intervention)
Secondary outcome [14] 421484 0
Changes in gut microbiota composition. This will be measured by shot-gun metagenome sequencing of DNA extracted from stool samples, and reported as measures of abundance and diversity.
Timepoint [14] 421484 0
Baseline and Week 10 (end of intervention)
Secondary outcome [15] 421485 0
Process evaluation of the Zesty Kids study, including a quantitative analysis. This will be measured by questionnaires completed by teachers, parent/caregivers and children, which ask respondents to rate their appreciation of individual intervention components on a Likert scale from 1-5. Mean scores will be reported. Questionnaires are designed specifically for this study.
Timepoint [15] 421485 0
Week 10 (end of intervention)
Secondary outcome [16] 421486 0
Process evaluation of the Zesty Kids study, including a qualitative analysis of semi-structured interviews with teachers, parents/caregivers and children to understand participants' experience with the intervention. This feedback will be assessed as a composite secondary outcome.
Timepoint [16] 421486 0
Week 10 (end of intervention)
Secondary outcome [17] 421934 0
Changes to fruit and vegetable intake from baseline to the 10-week follow-up. This will reported as serves/day by children, and measured by a modified version of the SPAN (School Physical Activity and Nutrition) questionnaire which has been adapted to the New Zealand context and for use in this study.
Timepoint [17] 421934 0
Baseline and Week 10 (end of intervention)
Secondary outcome [18] 421935 0
Children's mental health. This will be measured by the PROMIS positive affect questionnaire completed by children, and reported as mean scores.
Timepoint [18] 421935 0
Baseline and Week 10 (end of intervention)

Eligibility
Key inclusion criteria
The main study population are children in school years 4-6 attending a primary school in Tamaki Makaurau, Auckland. Children will be recruited through classrooms, where primary school principals and teachers have consented for their classroom to participate. Any child in a participating classroom in school years 4-6 (approximate age range: 7 - 11 years old) can take part in the dietary intervention if they are able to provide written informed assent and complete outcome assessments.

Parents/caregivers and teachers of children in participating classrooms will also provide outcome data and therefore are considered as participants in this research. Any parent/caregiver of a child in a participating classroom can take part in the study if they are able to provide informed consent and complete outcome assessments. Any teacher of a participating classroom (i.e., a classroom where the principal has already provided consent) can take part in the study if they are able to provide informed consent, are willing for their classroom to participate in the planned intervention components and assessments during school hours, and are able to complete outcome assessments.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individual children within the classroom may be excluded from data collection if they are unable to complete cognitive and psychosocial assessments (e.g., significant autism, unable to speak/understand English). Parents/caregivers may be excluded from data collection if they are unable to complete assessments (e.g., unable to speak/understand English or poor health literacy), though this does not exclude their child from data collection or participation in the study if the child themselves fulfils inclusion criteria.

There are no specific health or demographic criteria which would exclude teachers from taking part in this study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. Procedures for consent and baseline data collection will be completed before allocation is revealed to teachers, parents/caregivers, and children.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization to the intervention or control arm is performed at the level of the classroom.

Treatment allocation will be performed by an independent statistician in the order of enrollment date in the study using a randomised block design. Blocks will be stratified according to tertiles of the New Zealand Equity Index for schools. This stratified approach is followed to ensure that schools well-matched for socioeconomic status are matched in their randomisation to intervention and control arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a cluster-randomized controlled trial. Clustering is at the classroom level, with all students in the same classroom receiving the same intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The literature regarding pilot trial sample size estimation suggests approximately 100 children are required. Sample size requirements are more complex to define in cluster randomized trials, but guidelines suggest a minimum of at least 2 clusters (classrooms) in each intervention group. Within the parameters of a cluster-randomised pilot/feasibility trial recruiting 4 classrooms will satisfy both guidelines (2 classrooms in each intervention group, approximately 100 students at 80% consent rates).

Data on primary outcomes related to feasibility will be presented as descriptive statistics, with differences between intervention groups analysed by t-tests or chi-squared tests for continuous and categorical data, respectively.

Group differences in changes to secondary outcome data (dietary intake, nutrition behaviours, mental health, cognitive performance) will be evaluated by linear mixed models which account for clustering as a random effect and other mediating factors (e.g., baseline measures, demographic characteristics) as fixed effects. This allows for within-subject (pre/post comparisons) and between subject (intervention group) comparisons.

Thematic analysis will be performed on qualitative data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2023
Actual
15/08/2023
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 25427 0
New Zealand
State/province [1] 25427 0
Auckland

Funding & Sponsors
Funding source category [1] 313758 0
Commercial sector/Industry
Name [1] 313758 0
Zespri Group Ltd.
Country [1] 313758 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road
Grafton
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 315590 0
None
Name [1] 315590 0
None
Address [1] 315590 0
None
Country [1] 315590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312929 0
Health and Disability Ethics Committee, Southern Committee
Ethics committee address [1] 312929 0
Ministry of Health Health and Disability Ethics Committees
133 Molesworth Street,
Thorndon Wellington 6011
Ethics committee country [1] 312929 0
New Zealand
Date submitted for ethics approval [1] 312929 0
22/06/2023
Approval date [1] 312929 0
24/07/2023
Ethics approval number [1] 312929 0

Summary
Brief summary
Childhood is a critical period to promote and protect mental well-being, which has a strong influence on lifelong health and social outcomes. However, the prevalence of long-standing mental health conditions has increased in children and young people in the last two decades, and 1 in 7 young people are now estimated to be living with a diagnosed mental health disorder globally. Improving children’s mental well-being is a global public health priority

Nutrition is a modifiable lifestyle factor both at individual and societal levels, with extensive links to both mental health and cognitive function. There is now a substantial body of evidence linking diet quality with mental health indicators, and accumulating evidence from whole-diet interventions which show improvements in cognitive function or symptoms of anxiety or depression in adults. There is scarce comparable literature in children.

While attempting to change total diet quality in children is an impractical endeavor, a dietary intervention which promotes increased fruits and vegetables is a logical starting point to build this evidence base - particularly as improving low fruit and vegetable intake is already a public health priority. Although not specifically in children, a short two-week intervention found that increased fruit and vegetable intake led to improvements in mental well-being in young adults who are low fruit and vegetable consumers. There is convincing evidence from cross-sectional studies to suggest that an increase in fruit and vegetable intake would also lead to improved outcomes relating to mental health and cognitive performance in children.

The primary aim of this study is to determine the feasibility and acceptability of a 10-week fruit and vegetable dietary intervention in children in New Zealand school years 4-6 which measures mental and cognitive health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126374 0
Prof Clare Wall
Address 126374 0
Discipline of Nutrition, Faculty of Medical and Health Sciences
University of Auckland
85 Park road
Grafton
Auckland, 1023
Country 126374 0
New Zealand
Phone 126374 0
+64 9 923 9875
Fax 126374 0
Email 126374 0
c.wall@auckland.ac.nz
Contact person for public queries
Name 126375 0
Dr Nicola Gillies
Address 126375 0
Trial Coordinating Investigator
Discipline of Nutrition, Faculty of Medical and Health Sciences
University of Auckland
85 Park road
Grafton
Auckland, 1023
Country 126375 0
New Zealand
Phone 126375 0
+64 22 087 8065
Fax 126375 0
Email 126375 0
n.gillies@auckland.ac.nz
Contact person for scientific queries
Name 126376 0
Dr Nicola Gillies
Address 126376 0
Trial Coordinating Investigator
Discipline of Nutrition, Faculty of Medical and Health Sciences
University of Auckland
85 Park road
Grafton
Auckland, 1023
Country 126376 0
New Zealand
Phone 126376 0
+64 22 087 8065
Fax 126376 0
Email 126376 0
n.gillies@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared as this will not meet the requirements for ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19056Study protocol  n.gillies@auckland.ac.nz
19057Informed consent form  n.gillies@auckland.ac.nz
19058Ethical approval  n.gillies@auckland.ac.nz



Results publications and other study-related documents

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