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Trial registered on ANZCTR


Registration number
ACTRN12620001347954
Ethics application status
Approved
Date submitted
6/10/2020
Date registered
14/12/2020
Date last updated
12/11/2021
Date data sharing statement initially provided
14/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
OzHarvest’s FEAST (Food Education and Sustainability Training) Program: promoting healthy eating, food waste reduction and cooking skills in Year 5 and 6 children in Australian primary-schools.
Scientific title
Impact of OzHarvest’s FEAST (Food Education and Sustainability Training) Program on fruit and vegetable consumption in Year 5 and 6 children in Australian primary-schools: A non-randomised controlled trial.
Secondary ID [1] 302473 0
NSW State Education Research Applications Process (SERAP No. 2019163).
Secondary ID [2] 302475 0
National Health and Medical Research Council (NHMRC) Postgraduate Scholarship (NHMRC APP1191162).
Universal Trial Number (UTN)
U1111-1258-8724
Trial acronym
FEAST-NRCT

Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Promotion of healthy diet choices 319305 0
Condition category
Condition code
Public Health 317276 317276 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STUDY DESIGN:
This study is a pragmatic, parallel, cluster non-randomized controlled trial (NRCT) involving pre-post measures, within primary schools in New South Wales, Australia. It will involve 20 schools (10 intervention vs 10 wait-list control) with children in Years 5 and 6 (aged 10-12 years).
Schools will self-select to participate in the FEAST program during 2021, in the school term that best fits in with their academic schedule. The intervention will run for one school term i.e. 10 weeks. Pre- and post-intervention surveys will be issued in Weeks 1 and 10 respectively.
Schools participating in the FEAST program during Term 2 will be invited to participate in the trial as the intervention schools. Schools from Terms 3 and 4, will be invited to participate in the trial and will act as the wait-list control schools.

INTERVENTION:
The FEAST program was designed by OzHarvest, one of Australia’s leading not-for-profit, non-governmental food rescue organizations. FEAST is a primary-school, classroom-based, curriculum-aligned program, that uses inquiry-based approaches to learning, which are student-centred and interactive.

The objectives of the FEAST program are to educate children about healthy eating and reducing food waste, while teaching them to prepare and cook food.

The primary aim of this trial is to assess the immediate effectiveness of the program in increasing F&V consumption among primary-school-aged children. As secondary outcomes of the trial, the study will assess F&V variety intakes and the following food literacy constructs: nutrition knowledge, food preparation and cooking skills, self-efficacy and behaviours (preparing food, following recipes, and frequency of cooking dinner); food waste knowledge and behaviours (willingness to eat ‘imperfect’ F&V, and daily food lunch box waste behaviours); as well as food production knowledge (understanding the ‘farm to plate’ concept). Furthermore, a process evaluation will be conducted to assess program: reach (students and teachers); adoption (by schools); implementation (training of teachers, adherence by students and teacher, facilitators and barriers to implementation); maintenance (intention by students and teachers); satisfaction (by students and teachers); and perceived benefits (by teachers for their students).

OzHarvest provides training, structure, and support to teachers to deliver one 1.5-hour lesson/week, for a 10-week unit of inquiry (incorporating theory and practical activities). The FEAST program has been integrated with lessons mapped to the Australian Curriculum, embracing Year 5-6 key learning areas (KLAs)(English); STEM (Science, Technology, Engineering, Mathematics); cross-curriculum priority of Sustainability; and General Capabilities (Literacy, Numeracy, Information and Communication Technologies, Critical and Creative Thinking, Personal and Social Capability and Intercultural Understanding). FEAST has been aligned with the Australian Dietary Guidelines and state/territory-based healthy eating strategies, with all recipes including either fruit and/or vegetables. The program includes a range of educational resources designed to assist in the delivery of the theoretical and practical components.

Access to information is available at: https://education.ozharvest.org/about-feast/

RESOURCES:

(a) A Professional Learning Program
- options are face-to-face or online training.

(b) A Class Kitchen Kit and Apron pack.
- providing food preparation and cooking utensils for 30 students to prepare and cook in the classroom setting.
- provisions to purchase class kitchen kits, aprons and electric frypans.

(c) Web Portal – for Teachers, providing:
-Practical Guide (e.g. Risk assessment, order sheets, safety information)
-Recipe Books (6 Hot and 6 Cold recipes)
-Lesson Plans (aligned with the Australian Curriculum: STEM; Key Learning Areas; cross-curricular priority area of Sustainability; and General Capabilities).
-Unit of Work (the essential ingredients needed to teach FEAST, such as teaching notes, information about the teaching approach, fact sheets, and curriculum descriptors)
-Student worksheets
-Teacher Answer Booklet
-Cookbook template (for a School Family Cookbook)
-Optional Learning Experiences to use extra-curricular extension activities, such as: How to promote the School Family Cookbook; Healthy Eating and Nutrition; Let’s Cook up a Healthy Snack; Promote Sustainable Ways to Reduce Your Foodprint; Traffic Light Quiz and the Australian Guide to Healthy Eating; STEM Challenges (Using up fruit in a recipe; Create your own ‘use it up’ recipe; Create a recipe with vegetables from the bottom of the fridge; What goes into the production of fruit and vegetables?)

Access to an outline of teacher resources can be found at:
https://feast.ozharvest.org/shop/viewitem/feast-classroom-curriculum-package

(d) Web Portal – for Students, providing:
-Digital resources for students to learn all about reducing food waste and healthy eating
- Printable resources for students to complete activities during the program
- Optional learning activities (as listed in teacher resources above)
- Cookbook template (for a School Family Cookbook)
- Recipe Books (6 Hot and 6 Cold recipes)
- Ways to reduce their environmental footprint
- OzHarvest video, describing the charity’s fight on food waste and mission to nourish the country.

Access to examples of student cookbooks can be found at:
https://education.ozharvest.org/schools-cookbook/

(e) FEAST at Home portal:
(i) Activities and recipes for parents/caregivers to start cooking with their children at home.
(ii) Activities to reduce food waste at home.
(iii) Activities and games for the family to engage in, about healthy eating and food waste.

Access to portal:https://education.ozharvest.org/home-resources/


PROCEDURES & ACTIVITIES:
Six out of the 10 weekly FEAST sessions involve hands-on experiential food preparation and cooking activities in the classroom. To assist the teachers and children during the class practical components, teachers will be provided with instructions and resources to seek volunteers throughout the school community such as parents/caregivers, grandparents, and/or school staff etc. Trained volunteers will also be available through OzHarvest, to assist during the practical components. It is recommended that the teachers organise at least one adult per five students, for each of the practical sessions, in addition to themselves.

INTERVENTION DELIVERY:
The classroom teachers will be trained to deliver the FEAST program during regular class times, within the classroom setting, as the program has been integrated into the Australian curriculum.

The schools that volunteer to participate in the FEAST program will have the Year 5 and 6 classroom teachers trained by OzHarvest’s FEAST manager and education team. A Professional Learning Program which has been accredited by the NSW Education Standards Authority (NESA), will be delivered over six hours for the face-to-face training. During the training day, two FEAST Education Team members will train the teachers in food preparation and cooking skills (making the hot and cold recipes designed for the FEAST program).

For teachers who live in rural and regional locations and cannot attend the face-to-face training sessions at OzHarvest training centres, an online teacher training module was developed. These teachers will also have access to the same online resources as listed above in addition to:

The online FEAST program which involves:
- Teacher instructions on how to use the online learning resources and adapt them to the students’ needs and to prepare students for the online program (provide access to student portal; printable worksheets; etc);
- Lesson plans as outlined for the face-to-face training above;
- How to create the School Family Cookbook and plan and execute the cookbook launch;
- Instructional videos on how to conduct practical cooking sessions with good cooking techniques for making some of the recipes at home, which include parent roles.

The teachers using online training can work through the training module at their own pace.

MODE OF DELIVERY:
The FEAST program was originally designed for face-to-face delivery, by the classroom teacher to their students as a group, within the classroom setting. However, to cater for COVID19 restrictions an online program was also developed.

DURATION/INTENSITY OF INTERVENTION:
The FEAST course is designed for ten, 1.5 hours sessions per week, during one Australian primary-school term, i.e. approximately 10 weeks. Six out of the ten FEAST classes will involve the practical component, i.e. hands-on food preparation and cooking skills. Each individual teacher will schedule the FEAST program to fit into their weekly schedule integrating the FEAST learnings within the Australian Curriculum key learning areas of Science, Technology, English, Maths, and Sustainability.

LOCATION:
FEAST will be delivered in the classroom setting within primary schools participating in OzHarvest’s FEAST program in NSW, Australia, in urban and/or rural settings. Schools do not require a kitchen, as all recipes and equipment have been designed to be used within the classroom setting.

ADHERENCE MONITORING:
To monitor adherence to the program, the post-FEAST teacher survey includes questions that ask teachers: how many of their students participated in the FEAST program; what type of training they undertook (face-to-face vs online vs no training); if they implemented the program alone or with another teacher; how many FEAST lessons were undertaken; how many cooking sessions were conducted; and if the class created a School Cookbook. Also, there is a question embedded within the student post-FEAST survey asking students whether they participated in the cooking activities.
Intervention code [1] 318769 0
Behaviour
Intervention code [2] 318971 0
Lifestyle
Comparator / control treatment
The comparator will be schools that continue their usual academic programs during Term 2. These schools will complete the pre and post-FEAST surveys in Term 2 at the same time as the intervention schools. They will be on a self-selected wait-list to undertake the FEAST program during the school terms following the completion of the FEAST program by the intervention schools. The comparator schools will undertake the FEAST program during the school terms of their choice, i.e. in Term 3 or 4.
Control group
Active

Outcomes
Primary outcome [1] 325331 0
Fruit consumption: Number of serves of fruit consumed/day: assessed by student self-reported study-specific questionnaire.

Changes in consumption of fruit servings/day, will be calculated as the mean difference, between baseline and post-intervention (with 95% CI).

The first two questions, that relate to children’s F&V consumption have been chosen from the food frequency questionnaire (FFQ) used in the Many Rivers Diabetes Prevention Project.(Gwynn et al, 2011) This FFQ has been used among Australian children aged 10-12 years, and has been assessed for criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [1] 325331 0
Baseline: Week one of the school term, in which the FEAST program will be implemented (i.e. Timepoint 1: T1).
Post-Intervention: Last week of the school term in which the FEAST program has been implemented (i.e. Timepoint 2: T2).
Primary outcome [2] 325332 0
Vegetable consumption: Number of serves of vegetables consumed/day: assessed by student self-reported study-specific questionnaire.

Changes in consumption of vegetable servings/day, will be calculated as the mean difference, between baseline and post-intervention (with 95% CI).

The first two questions, that relate to children’s F&V consumption have been chosen from the food frequency questionnaire (FFQ) used in the Many Rivers Diabetes Prevention Project.(Gwynn et al, 2011) This FFQ has been used among Australian children aged 10-12 years, and has been assessed for criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [2] 325332 0
Baseline (Pre-Intervention). Timepoint 1: T1 Week one of the school term, in which the FEAST program will be implemented.
Post-Intervention: Timepoint 2: T2 Last week of the school term in which the FEAST program has been implemented.
Secondary outcome [1] 387565 0
Fruit consumption: Percentage of students consuming 2 or more fruits/day: assessed by student self-reported study-specific questionnaire.

Given the average intake of fruit for Australian children is 2.2 serves/day, which meets national recommendations,(Australian Bureau of Statistics, 2018) a level of 2 serves/day will be used to assess changes in the proportion of students consuming fruits, between pre- to post-FEAST.
The questions, that relate to children’s F&V consumption have been chosen from the food frequency questionnaire (FFQ) used in the Many Rivers Diabetes Prevention Project.(Gwynn et al, 2011) This FFQ has been used among Australian children aged 10-12 years, and has been assessed for criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [1] 387565 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [2] 387566 0
Vegetable consumption: Percentage of students consuming 2 or more vegetables/day: assessed by student self-reported study-specific questionnaire.

According to the Australian Bureau of Statistics, only 6.3% of children meet their recommended intake of five vegetables/day, with an average intake of two serves/day (Australian Bureau of Statistics, 2018). Therefore, a more conservative level of 2 serves/day will be used to assess changes in the proportion of students consuming vegetables, pre- to post-FEAST.

The questions, that relate to children’s F&V consumption have been chosen from the food frequency questionnaire (FFQ) used in the Many Rivers Diabetes Prevention Project.(Gwynn et al, 2011) This FFQ has been used among Australian children aged 10-12 years, and has been assessed for criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [2] 387566 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [3] 387567 0
Fruit variety: the number of different types of fruits consumed yesterday: assessed by student self-reported study-specific questionnaire.

For fruit variety (number of different types of fruits consumed yesterday), the mean number of the variety of the different fruits consumed will be calculated between baseline and post-intervention (with 95% CI). To capture variety of fruits eaten by children, one question was taken from the Modified Child Nutrition Questionnaire (MCNQ),(Wilson, 2008) which was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012) However, there has been an addition of ‘other’ under the list of fruits listed in this question, with the opportunity to state which ‘other’ fruits children consume. This was used in order to capture the different varieties of fruits consumed by children from culturally and linguistically diverse (CALD) backgrounds. The inclusion of questions that are sensitive to populations that are CALD, was one of the lessons learnt from the FEAST pilot study, given the schools that participated in the pilot, had a high percentage of students that were from diverse ethnic backgrounds, as well as a small percentage of students from Indigenous backgrounds.
Timepoint [3] 387567 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [4] 387568 0
Vegetable variety: number of different types of vegetables consumed yesterday: assessed by student self-reported study-specific questionnaire.

For vegetable variety (number of different types of vegetables consumed yesterday), the mean number of the variety of the different vegetables consumed will be calculated between baseline and post-intervention (with 95% CI). To capture variety of vegetables eaten by children, one question was taken from the Modified Child Nutrition Questionnaire (MCNQ),(Wilson, 2008) which was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012) However, there has been an addition of ‘other’ under the list of vegetables listed in this question, with the opportunity to state which ‘other’ vegetables children consume. This was used in order to capture the different varieties of vegetables consumed by children from culturally and linguistically diverse (CALD) backgrounds. The inclusion of questions that are sensitive to populations that are CALD, was one of the lessons learnt from the FEAST pilot study, given the schools that participated in the pilot, had a high percentage of students that were from diverse ethnic backgrounds, as well as a small percentage of students from Indigenous backgrounds.
Timepoint [4] 387568 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [5] 388499 0
Fruit variety: Percentage of students consuming variety of fruit yesterday: assessed by student self-reported study-specific questionnaire.

For fruit variety (number of different types of fruits consumed yesterday), the proportion (in percentages %) of students consuming these fruits will be calculated. To capture variety of fruits eaten by children, one question was taken from the Modified Child Nutrition Questionnaire (MCNQ),(Wilson, 2008) which was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [5] 388499 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [6] 388500 0
Vegetable variety: Percentage of students consuming variety of vegetables yesterday: assessed by student self-reported study-specific questionnaire.

For vegetable variety (number of different types of vegetables consumed yesterday), the proportion (in percentages %) of students consuming these vegetables will be calculated. To capture variety of vegetables eaten by children, one question was taken from the Modified Child Nutrition Questionnaire (MCNQ),(Wilson, 2008) which was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [6] 388500 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [7] 388501 0
Nutrition knowledge: percentage of students knowing the recommended intake of fruit serves/day: assessed by student self-reported study-specific questionnaire.

The question for this outcome was taken from the Modified Child Nutrition Questionnaire (MCNQ), (Wilson, 2008) however the multiple-choice responses were modified and simplified to include only specific servings/day with the exclusion of responses that included servings/week. The MCNQ was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [7] 388501 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [8] 388502 0
Nutrition knowledge: percentage of students knowing recommended intake of vegetable serves/day: assessed by student self-reported study-specific questionnaire.

The question for this outcome was taken from the Modified Child Nutrition Questionnaire (MCNQ), (Wilson, 2008) however the multiple-choice responses were modified and simplified to include only specific servings/day with the exclusion of responses that included servings/week. The MCNQ was designed to assess dietary patterns in Australian children aged 9-13 years, and has face/content validity, criterion/concurrent/predictive validity and reliability.(Australian Child and Adolescent Obesity Research Network, 2012)
Timepoint [8] 388502 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [9] 388504 0
Cooking skills/self-efficacy: percentage of students reporting the ability to make snack (fruit): assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can make a fruit snack, will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [9] 388504 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [10] 388505 0
Cooking skills/self-efficacy: percentage of students reporting the ability to make snack (vegetables): assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can make a vegetable snack, will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [10] 388505 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [11] 388506 0
Cooking skills/self-efficacy: percentage of students reporting the ability to make food (salad): assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can make a salad will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [11] 388506 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [12] 388507 0
Cooking skills/self-efficacy: percentage of students reporting they help their family make a meal: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they help their family make a meal, will be calculated between baseline and post-intervention. This question, was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [12] 388507 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [13] 388508 0
Cooking skills/self-efficacy: percentage of students reporting they can cut up food: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can cut up food, will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [13] 388508 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [14] 388509 0
Cooking skills/self-efficacy: percentage of students reporting they can measure ingredients: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can measure ingredients will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [14] 388509 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [15] 388510 0
Cooking skills/self-efficacy: percentage of students reporting they can follow a recipe: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting that they can follow a recipe will be calculated between baseline and post-intervention. This question was taken from the survey used in the ‘Cooking with Kids’ program and has been validity-tested for self-efficacy among children aged 9-11 years. (Lohse et al, 2011)
Timepoint [15] 388510 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [16] 388511 0
Cooking behaviour: percentage of students reporting the number of times/week helping to cook at home: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting they ‘help cook dinner at home’ will be calculated between baseline and post-intervention. This question was taken from the survey used in
the Experiential Cooking and Nutrition Education Program, that was designed to increase cooking self-efficacy and vegetable consumption in children in Grades 3–8. (Jarpe-Ratner et al, 2016) The survey used for that study was not tested for validity and/or reliability.
Timepoint [16] 388511 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [17] 388512 0
Food waste behaviour: percentage of students reporting the amount of school lunch consumed: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting the amount of their school lunch consumed will be calculated between baseline and post-intervention. This question was modified from one published study investigating food waste behaviours among children in Western Australian upper primary and lower secondary schools (Grades 5-8).{Boulet, 2019 #1302} However, this survey has not been validated to date.
Timepoint [17] 388512 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [18] 388513 0
Food waste knowledge: the percentage of students reporting understanding of the impact of food waste on the environment: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting understanding of the impact of food waste on the environment will be calculated between baseline and post-intervention. The question for this outcome was specifically developed for the FEAST program and was aligned with food waste lessons.
Timepoint [18] 388513 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [19] 388514 0
Food production: the percentage of students reporting the correct sequence of farm to plate: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting the correct sequence of farm to plate will be calculated between baseline and post-intervention. The question for this outcome was specifically developed for the FEAST program and was aligned with the food production lesson.
Timepoint [19] 388514 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [20] 388515 0
Food waste behaviour: percentage of students reporting eating ‘imperfect’ fruit and vegetables: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting their willingness to eat ‘imperfect’ fruit and vegetables will be calculated between baseline and post-intervention. The questions for this outcome was specifically developed for the FEAST program and was aligned with food waste lessons.
Timepoint [20] 388515 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [21] 388516 0
Food waste behaviour: percentage of students reporting eating ‘imperfect’ bananas: assessed by student self-reported study-specific questionnaire.

The proportion of students reporting their willingness to eat ‘imperfect’ bananas will be calculated between baseline and post-intervention. The questions for this outcome was specifically developed for the FEAST program and was aligned with food waste lessons.
Timepoint [21] 388516 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [22] 388517 0
Program Evaluation: Student satisfaction with program: assessed by student self-reported study-specific questionnaire.
Timepoint [22] 388517 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [23] 388518 0
Program Evaluation: Teacher satisfaction with program content, resources, and implementation: assessed by self-reported study-specific questionnaire.
Timepoint [23] 388518 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2
Secondary outcome [24] 389778 0
A score for self-efficacy for cooking skills, will be calculated, where students report whether they can: make a fruit snack; make a vegetable snack; make a salad; help their family make a meal; cut up food; measure ingredients; and follow a recipe: assessed by self-reported study-specific questionnaire.

The mean score of the number of ‘yes’ responses to these questions will be calculated out of a possible seven ‘yes’ responses, and compared between baseline and post-intervention. The seven questions to assess these outcomes were taken from the survey used in the ‘Cooking with Kids’ program and have been validity-tested for self-efficacy among children aged 9-11 years. (Lohse, 2011)
Timepoint [24] 389778 0
Baseline (Pre-Intervention). Timepoint 1: T1
Post-Intervention: Timepoint 2: T2

Eligibility
Key inclusion criteria
Study setting:
Government or non-government (including faith-based) primary schools.
In urban or rural locations
Computer access for all students
Participants:
Students in Year 5 or 6 or composite Year 5/6 classes
Students with a school email address
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools that cater exclusively to children with special needs, particular health conditions, and/or schools that have already been involved in the FEAST program previously, will be ineligible.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATIONS
Based on current enrolments into the 2020 FEAST program from OzHarvest, it is anticipated that 20 schools (10 per intervention arm) will take part in this study, with an average of 50 students (SD=22, and therefore CV=0.436) per arm. A within-school intraclass correlation of 0.04 is estimated for both primary outcomes of fruit and vegetable intakes,(1-3) and correlations of 0.5 are assumed between outcome measures between baseline and 10 weeks.(4) Standard deviations for vegetable and fruit serves/day are estimated to be 1.3 and 1.1 respectively, according to the South Australian Health Report from 2015 on children's vegetable intake(5) and fruit intake.(6) Allowance will be made for 20% loss due to follow-up or missing data.(2, 7)
Given there are two primary outcomes, a Bonferroni-corrected alpha of 0.05/2 = 0.025 will be used. An increase of 0.5 servings of fruit/vegetables per day may be considered clinically meaningful,(4, 8) and under the above assumptions, the study would provide 90% power to detect an intervention effect of this size, for the vegetable intake outcome and 97% power for the fruit intake outcome.

STATISTICAL ANALYSIS

Demographic and baseline characteristics will be summarised for both intervention and control groups and compared for differences at baseline. Standard summary statistics (mean and standard deviation [SD]) or non-parametric statistics (medians and inter-quartile ranges) will be used appropriately. For the categorical variables, frequencies and percentages will be calculated and reported.

Effects of the intervention on study outcomes will be estimated with generalised linear mixed models (GLMMs) including random intercepts to account for clustering within schools and fixed effects of intervention arm, using appropriate family and link functions according to outcome distribution or type. Models will be adjusted for potential confounders: gender, grade, Index of Community Socio-Educational Advantage (ICSEA), type of teacher training (face-to-face vs online), and whether the student speaks another language at home (which will be dichotomised as Yes/No). Analyses will also adjust for baseline levels of the desired outcome. Intracluster correlation coefficients (ICC) for within-school clustering in each intervention effect model will be calculated and reported. Similarly, within-group changes in outcomes will be estimated using GLMMs including random effects for schools and individuals, and fixed effects of time. Estimated intervention effects and within-group changes will be reported as unstandardised regression coefficients or exponentiated coefficients (e.g., odds ratios), with 95% confidence intervals and p-values.

All analyses will follow the intention-to-treat (ITT) principles and missing data will be handled using multiple imputation by chained equations.(9) Imputation models will be run separately by intervention arm and will include school ID and all outcome and covariate measures. Multiple imputation analyses provide valid inference and unbiased estimates of intervention effects under a missing at random assumption (i.e., data is missing at random conditional on the observed data).(9)

Furthermore, to assess sensitivity of the findings to different assumptions around the missing data mechanism, complete case analyses (valid under a missing completely at random assumption) will also be conducted as a sensitivity analysis. No interim analyses of trial outcomes are planned nor any stopping rules.

Analyses for the process evaluation, involving responses from students and teachers, will involve descriptive statistics for the quantitative component using standard summary statistics. While the qualitative component, which involves responses to open-ended questions, will be analysed using both content and thematic analyses, as well as qualitative description.(10, 11)

References:
1. Lawlor DA, Peters TJ, Howe LD, et al. The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan. Trials. 2013;14:234.
2. Lawlor DA, Jago R, Noble SM, et al. The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial. Trials. 2011;12:181.
3. Jago R, Rawlins E, Kipping RR, et al. Lessons learned from the AFLY5 RCT process evaluation: implications for the design of physical activity and nutrition interventions in schools. BMC Public Health. 2015;15(1):946.
4. Wilson AM, Magarey AM, Mastersson N. Reliability and relative validity of a child nutrition questionnaire to simultaneously assess dietary patterns associated with positive energy balance and food behaviours, attitudes, knowledge and environments associated with healthy eating. International Journal of Behavioral Nutrition and Physical Activity 2008;5:5.
5. University of Adelaide, South Australia Health, Australia. GoS. Vegetable Consumption: State, Metropolitan and Country. Children aged 2 to 17 years Adelaide, South Australia.: University of Adelaide; 2015 [cited 2019 July, 30]. Available from: https://www.sahealth.sa.gov.au/wps/wcm/connect/fa082c004dbc99178e16af46e4df54bc/Vegetable+Consumption+2015+-+Children+-+Target.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-fa082c004dbc99178e16af46e4df54bc-mMA9Rjd.
6. University of Adelaide, South Australia Health, Australia. GoS. Fruit Consumption: State, Metropolitan and Country. Children aged 2 to 17 years Adelaide, South Australia.: University of Adelaide; 2015 [cited 2019 July, 30]. Available from: https://www.sahealth.sa.gov.au/wps/wcm/connect/846602804dbc93e38d37ad46e4df54bc/Fruit+Consumption+2015+-+Children+-+Target.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-846602804dbc93e38d37ad46e4df54bc-mMz3AlU.
7. Arrizabalaga-Lopez M, Rada-Fernandez de Jauregui D, Portillo MP, et al. A randomised controlled trial of a program based on the theory of planned behavior to promote fruit and vegetable intake among schoolchildren: PROFRUVE study protocol. BMC Public Health. 2018;18(1):827.
8. Glasson C, Chapman K, Gander K, et al. The efficacy of a brief, peer-led nutrition education intervention in increasing fruit and vegetable consumption: a wait-list, community-based randomised controlled trial. Public Health Nutr. 2012;15(7):1318-26.
9. Li P and Stuart EA. Best (but oft-forgotten) practices: missing data methods in randomized controlled nutrition trials. The American journal of clinical nutrition. 2019;109(3):504-8.
10. Bradshaw C, Atkinson S, Doody O. Employing a Qualitative Description Approach in
Health Care Research. Global Qualitative Nursing Research. 2017;4:2333393617742282.
11. Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000;23(4):334-40.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
14/05/2021
Date of last participant enrolment
Anticipated
5/10/2021
Actual
14/07/2021
Date of last data collection
Anticipated
17/12/2021
Actual
Sample size
Target
1000
Accrual to date
Final
1054
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32176 0
2250 - Gosford
Recruitment postcode(s) [2] 32177 0
2153 - Baulkham Hills
Recruitment postcode(s) [3] 32178 0
2145 - Greystanes
Recruitment postcode(s) [4] 32179 0
2145 - Wentworthville
Recruitment postcode(s) [5] 32181 0
2289 - Adamstown Heights
Recruitment postcode(s) [6] 32182 0
2195 - Lakemba
Recruitment postcode(s) [7] 32183 0
2669 - Naradhan
Recruitment postcode(s) [8] 32190 0
2770 - Hebersham
Recruitment postcode(s) [9] 32191 0
2150 - Parramatta
Recruitment postcode(s) [10] 32192 0
2285 - Edgeworth
Recruitment postcode(s) [11] 32193 0
2770 - Lethbridge Park
Recruitment postcode(s) [12] 32194 0
2278 - Wakefield
Recruitment postcode(s) [13] 32195 0
2791 - Carcoar
Recruitment postcode(s) [14] 32196 0
2460 - Grafton
Recruitment postcode(s) [15] 32197 0
2620 - Gundaroo
Recruitment postcode(s) [16] 32198 0
2283 - Toronto
Recruitment postcode(s) [17] 32199 0
2325 - Cessnock
Recruitment postcode(s) [18] 32200 0
2747 - Cambridge Gardens
Recruitment postcode(s) [19] 32201 0
2283 - Awaba
Recruitment postcode(s) [20] 32202 0
2340 - Tamworth
Recruitment postcode(s) [21] 32203 0
2287 - Wallsend

Funding & Sponsors
Funding source category [1] 306898 0
Government body
Name [1] 306898 0
National Health and Medical Research Council (NHMRC)
Country [1] 306898 0
Australia
Funding source category [2] 306904 0
Charities/Societies/Foundations
Name [2] 306904 0
OzHarvest
Country [2] 306904 0
Australia
Primary sponsor type
Individual
Name
Fay Karpouzis
Address
Institution: Deakin University
Faculty: Health
School: School of Exercise and Nutrition Sciences
Institute: The Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country
Australia
Secondary sponsor category [1] 307458 0
Individual
Name [1] 307458 0
Professor Kylie Ball
Address [1] 307458 0
Institution: Deakin University
Faculty: Health
School: School of Exercise and Nutrition Sciences
Institute: The Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country [1] 307458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307052 0
Human Ethics Advisory Group, Faculty of Health, Deakin University
Ethics committee address [1] 307052 0
Ethics committee country [1] 307052 0
Australia
Date submitted for ethics approval [1] 307052 0
28/02/2020
Approval date [1] 307052 0
05/05/2020
Ethics approval number [1] 307052 0
HEAG-H 31_2020

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

Contacts
Principal investigator
Name 105858 0
Ms Fay Karpouzis
Address 105858 0
Faculty: Health
School: School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 105858 0
Australia
Phone 105858 0
+61 392517310
Fax 105858 0
Email 105858 0
fkarpouzis@deakin.edu.au
Contact person for public queries
Name 105859 0
Fay Karpouzis
Address 105859 0
Faculty: Health
School: School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 105859 0
Australia
Phone 105859 0
+61 392517310
Fax 105859 0
Email 105859 0
fkarpouzis@deakin.edu.au
Contact person for scientific queries
Name 105860 0
Fay Karpouzis
Address 105860 0
Faculty: Health
School: School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country 105860 0
Australia
Phone 105860 0
+61 392517310
Fax 105860 0
Email 105860 0
fkarpouzis@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data that supports the published results of this study will be made available only to researchers who provide a methodologically sound proposal. Proposals will be treated on a case-by-case basis and the final decision will be at the discretion of the Primary Sponsor.
When will data be available (start and end dates)?
The data will be made available beginning three months and ending five years following main results publication.
Available to whom?
The data that support the published results of this study will be made available only to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
The data will be made available only to achieve the aims in the approved proposal, and for IPD meta-analyses.
How or where can data be obtained?
The data will be made available by contacting the the Principal Investigator:
Fay Karpouzis PhD (Can)
fkarpouzis@deakin.edu.au


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9373Ethical approval    Deakin University Human Ethics Advisory Group has ... [More Details] 380700-(Uploaded-06-10-2020-13-41-13)-Study-related document.pdf
9622Study protocol  fkarpouzis@deakin.edu.au When the protocol is published, a link will be mad... [More Details]


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9373Ethical approval    Deakin University Human Ethics Advisory Group has ... [More Details] 380700-(Uploaded-06-10-2020-13-41-13)-Study-related document.pdf
9622Study protocolKarpouzis F, Lindberg R, Walsh A, et al. 2021. Evaluating OzHarvest’s primary-school Food Education and Sustainability Training (FEAST) program in 10–12-year-old children in Australia: protocol for a pragmatic cluster non-randomized controlled trial. BMC Public Health. 21(1):967.https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-10302-0fkarpouzis@deakin.edu.au Protocol published and citation and link added

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating OzHarvest's primary-school Food Education and Sustainability Training (FEAST) program in 10-12-year-old children in Australia: protocol for a pragmatic cluster non-randomized controlled trial.2021https://dx.doi.org/10.1186/s12889-021-10302-0
N.B. These documents automatically identified may not have been verified by the study sponsor.