Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000392965
Ethics application status
Approved
Date submitted
10/03/2020
Date registered
23/03/2020
Date last updated
23/03/2020
Date data sharing statement initially provided
23/03/2020
Date results provided
23/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a new vegetable education program on factors associated with vegetable consumption in Australian primary school children
Scientific title
Effectiveness of a teacher led school based vegetable education program to change vegetable related behaviours in Australian primary school children
Secondary ID [1] 300726 0
VG15067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vegetable acceptance 316545 0
mediating factors of vegetable consumption 316546 0
vegetable consumption 316547 0
Condition category
Condition code
Public Health 314787 314787 0 0
Health promotion/education
Diet and Nutrition 314915 314915 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 with two intervention arms (and one control arm). The intervention arms are the same teacher-led school-based vegetable education program VERTICAL (Vegetable Education Resource To Increase Children’s Acceptance and Liking), preceded by differing teacher training intensity, as follows:
Arm 1: Intervention low: VERTICAL vegetable education intervention with low intensity teacher training (online and written materials)
Arm 2: Intervention high: VERTICAL vegetable education intervention with high intensity teacher training (as for ‘intervention low’ but with face-to-face training).

The VERTICAL resource is a new resource. An earlier version of the resource has been evaluated in a pilot study (Poelman et al, JNEB, 2017, 2019).
The VERTICAL intervention to students consists of 5 x 1 hour lessons, delivered once a week for 5 weeks. It is a classroom based program developed by sensory and consumer scientists, behavioural nutritionists and educators, and aims to positively prime children to consume vegetables. It is based on a scientific framework of food preference development and has elements of sensory education programs. It is curriculum aligned. Fun, enjoyment and experiential learning are critical elements of the program, with vegetables tasted in each of the lessons. There are three units of work for different stages of primary school (Foundation-Year 2, Year 3-4 and Year 5-6).

There are two forms of teacher training to prepare teachers to teach the vegetable education intervention, low and high intensity: 1) Low intensity training: teachers provided with lesson materials (fully written lessons plans), a written implementation manual, as well as an online training module taking around 20 minutes to complete. Teachers can undertake training in their own time at a time that suits. 2) High intensity training: teachers provided with the same materials as in the low intensity training (including the online training module), but additional interactive face-to-face (F2F) training (45 min) by research staff involved in the study. F2F training delivery 2-4 weeks prior to the intervention. Delivers information on the same elements as delivered through the written and online materials. In addition, school-specific implementation plans are discussed with staff and a hands-on exercise, illustrative of the program, conducted with teachers.

All teachers implementing the program are provided with a unique login for the online module. Adherence to the online training is monitored through an LMS platform. Adherence to the intervention through phone contact with the 'champion' for the study in each school and through reimbursement of costs for materials to implement the program. In addition, a teacher survey undertaken among teachers in the intervention arms evaluating the program and materials (results outside scope of current study).
Intervention code [1] 317046 0
Behaviour
Intervention code [2] 317047 0
Lifestyle
Comparator / control treatment
The control treatment consists of students following the regular school curriculum
Control group
Active

Outcomes
Primary outcome [1] 323146 0
Change in vegetable acceptance.
Vegetable acceptance measured by student report through online questionnaire. Overall measure of acceptance calculated as average of overall vegetable acceptance and acceptance of six specific vegetables (relevant to the unit taught). Measured using a 7-point hedonic facial scale.
Timepoint [1] 323146 0
Baseline, immediately after intervention [primary time point], 3 month follow up [to determine if effect is sustained]
Primary outcome [2] 323147 0
Change in behavioural intention to eat vegetables.
Behavioural intention measured by student report (through online questionnaire) using four statements (e.g. "I will eat a variety of vegetables") on a 5-point Likert scale. Format and response category according to validated scales of behavioural intent of the Theory of Planned Behaviour.
Timepoint [2] 323147 0
Baseline, immediately after intervention [primary time point], 3 month follow up [to determine if effect is sustained]
Primary outcome [3] 323148 0
Change in number of new vegetables tried
The number of new vegetables the child tried in the previous month (by student report through online questionnaire).
This question was designed specifically for this study. It is an an adaption of a questionnaire previously used in a pilot study evaluating the effect of a pilot version of the resource (Poelman et al, JNEB, 2019).
Timepoint [3] 323148 0
Baseline, immediately after intervention [primary time point], 3 month follow up [to determine if effect is sustained]
Secondary outcome [1] 380956 0
Change in knowledge in relation to vegetables and the senses involved in eating and drinking.
Knowledge tested through using a combination of multiple-choice questions, true/false statements and open questions. Student report through online questionnaire. Questions in part common across all year levels, with some questions specific to the unit taught. Maximum score of 11 points.
This questionnaire was designed specifically for this study. It has been used before in a pilot study evaluating the effect of a pilot version of the resource (Poelman et al, JNEB, 2019).
Timepoint [1] 380956 0
Baseline, immediately after intervention, 3 month follow up [to determine if effect is sustained]
Secondary outcome [2] 380957 0
Change in verbalisation ability
Ability to verbalisation sensory perceptions measured through provide descriptive words for two vegetables (specific to each unit taught). Student report through online questionnaire. The number of descriptive (e.g. crunchy, sweet) words is counted. Hedonic words (e.g. delicious, yummy) are excluded. One point is allocated for each correct answer. The number of descriptive terms summed across the two vegetables is calculated.
This questionnaire was designed specifically for this study. It has been used before in a pilot study evaluating the effect of a pilot version of the resource (Poelman et al, JNEB, 2019).
Timepoint [2] 380957 0
Baseline, immediately after intervention, 3 month follow up [to determine if effect is sustained]
Secondary outcome [3] 381091 0
Change in willingness to try vegetables

Willingness to try (yes/no) four specific (less commonly consumed) vegetables measured using pictures of the vegetables. Student report through online questionnaire. Sum score calculated for each vegetable the child is willing to try.

This questionnaire was designed specifically for this study. It has been used before in a pilot study evaluating the effect of a pilot version of the resource (Poelman et al, JNEB, 2019).
Timepoint [3] 381091 0
Baseline, immediately after intervention, 3 month follow up [to determine if effect is sustained]
Secondary outcome [4] 381092 0
Change in vegetable consumption.
Vegetable consumption data collected by parent report of child's usual vegetable consumption in serves/day. Measured using a validated scale for Australian adults (Ball et al,, Public Health Nutrition, 2006). Adapted for use by children by adding response categories 1/2 serve and 1 1/2 serve.
Timepoint [4] 381092 0
Baseline, 6 weeks after the intervention
Secondary outcome [5] 381093 0
Change in child's food neophobia.
Child's food neophobia reported by parents using a validated scale (Cooke et al, IJBNPA, 2006) which consists of level of agreement to six statements.
Timepoint [5] 381093 0
Baseline, 6 weeks after the intervention

Eligibility
Key inclusion criteria
Inclusion criteria for schools
• Government primary school
• School located in one of ten selected areas in Greater Sydney or Greater Adelaide
• A minimum of two teachers of each Stage willing to take part in the student validation study

Inclusion criteria for students:
• Student in year 2-6 of participating classroom within participating school
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for schools:
• Schools that cannot accommodate computerised data collection
• Schools that have previously been involved in trialling the vegetable education resource

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)
Eligibility of schools determined before treatment allocation. After treatment allocation, all teachers and students at the same school allocated to the same treatment condition (cluster-trial)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified approach is followed to recruit schools stratified for socio-economic status (SES). Scores for Index of Relative Socio-Economic Advantage and Disadvantage (IRSEAD) are obtained from the Statistical Local Areas (SLA) of Greater Sydney (NSW) and Greater Local Areas (GLA) in Greater Adelaide (SA). Tertile splits in each state are conducted to divide areas according to low (IRSEAD deciles 1-5), medium (IRSEAD deciles 6-8) and high (IRSEAD 9-10) socio-economic status. Areas with fewer than 6 schools are excluded. A total of 4, 3 and 3 (NSW) and 3, 3 and 4 (SA) areas with low, medium and high SES, respectively, are randomly selected from a list of all areas by an independent statistician using the ‘random number’ function in Excel (Microsoft Office). A list of government primary schools from each selected area is compiled using information from the Department of Education and all schools are invited to take part. Once schools are recruited into the study, they are randomly allocated to one of the three treatments (two intervention or control). Allocation to treatment is done by the principal investigator in the order of enrolment date in the study using a randomised block design for each state (SES levels were blocks) created by an independent statistician prior to recruitment in each state using R (version 3.4.2, using ‘block rand’ library v1.3).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Cluster-RCT.
Clustering at school/classroom level, with all students within the same classroom/school receiving the same intervention.

Students conduct an on-line survey. No direct link made between intervention and survey in information sheet. The information sheet and consent form study mentioned as study objective to investigate the effect of education activities on children's liking and consumption of foods, specifically of vegetables.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated based on a change in student behavioural intention outcomes with a small effect size of 0.15 based on comparable studies [Battjes-Fries et al, 2014, Public Health Nutrition; Poelman et al, JNEB, 2019]. With a power of 0.95, alpha = 0.05 and using a repeated exposure ANOVA with 3 treatment groups, an overall sample size of 531 students is needed (GPower 3.1.9.2). This sample size was multiplied by a correction factor of 1+ (m-1) ?, called the design effect (where m is the average cluster size and ? is the intra-class correlation coefficient), to take the clustered nature of the data into account [42]. Assuming an m of 25 students per class and estimating a small degree of correlation (? = 0.05), the correction factor is 2.2, leading to a minimum sample needed of 1168 students (531 × 2.2 = 1168). On a cluster level, data from 30 schools is sought (10 schools in each of the three treatment arms) to cover a wide geographic and socio-economic spread. With an estimated response rate in classes of around 30% [Wolfenden et al, 2009, ANZJPH)], and a minimum participation of 6 classes per school, data from a minimum of 1350 students are expected (30 schools x 6 classes x 25 students/class x 30% response rate).

Data analysed using mixed linear modelling on primary and secondary outcome measures taking the clustered nature of the data into account (students in classrooms, classrooms in schools). Gender, school size, SES of school areas and state included as co-variates in the model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/04/2018
Date of last participant enrolment
Anticipated
Actual
7/08/2018
Date of last data collection
Anticipated
Actual
13/12/2018
Sample size
Target
1350
Accrual to date
Final
1639
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 305178 0
Commercial sector/Industry
Name [1] 305178 0
Horticulture Australia Innovations Limited
Country [1] 305178 0
Australia
Funding source category [2] 305180 0
Government body
Name [2] 305180 0
Commonwealth Scientific and Industrial Research Organisation
Country [2] 305180 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation
Address
11 Julius Avenue, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 305566 0
None
Name [1] 305566 0
Address [1] 305566 0
Country [1] 305566 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305538 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 305538 0
Ethics committee country [1] 305538 0
Australia
Date submitted for ethics approval [1] 305538 0
14/11/2016
Approval date [1] 305538 0
13/01/2017
Ethics approval number [1] 305538 0
HREC24/2016
Ethics committee name [2] 305559 0
SERAP
Ethics committee address [2] 305559 0
Ethics committee country [2] 305559 0
Australia
Date submitted for ethics approval [2] 305559 0
06/02/2017
Approval date [2] 305559 0
05/04/2017
Ethics approval number [2] 305559 0
SERAP2017036
Ethics committee name [3] 305564 0
SA Department of Education
Ethics committee address [3] 305564 0
Ethics committee country [3] 305564 0
Australia
Date submitted for ethics approval [3] 305564 0
26/03/2018
Approval date [3] 305564 0
19/04/2018
Ethics approval number [3] 305564 0
2018-0032

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

Contacts
Principal investigator
Name 43166 0
Dr Astrid Poelman
Address 43166 0
CSIRO Agriculture &Food
11 Julius Avenue
North Ryde NSW 2113
Country 43166 0
Australia
Phone 43166 0
+61 2 9490 8356
Fax 43166 0
Email 43166 0
[email protected]
Contact person for public queries
Name 43167 0
Astrid Poelman
Address 43167 0
CSIRO Agriculture &Food
11 Julius Avenue
North Ryde NSW 2113
Country 43167 0
Australia
Phone 43167 0
+61 2 9490 8356
Fax 43167 0
Email 43167 0
[email protected]
Contact person for scientific queries
Name 43168 0
Astrid Poelman
Address 43168 0
CSIRO Agriculture &Food
11 Julius Avenue
North Ryde NSW 2113
Country 43168 0
Australia
Phone 43168 0
+61 2 9490 8356
Fax 43168 0
Email 43168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included as part of ethics approval


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.