Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001071112
Ethics application status
Approved
Date submitted
11/07/2019
Date registered
31/07/2019
Date last updated
16/09/2021
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cross-curricular Unit on Portion Size (CUPS): Evaluation of a school-based program integrating nutrition and mathematics.
Scientific title
A cluster randomised controlled trial investigating the efficacy of an integrated unit on nutrition and mathematics for the improvement of portion size estimation in primary school children.
Secondary ID [1] 298608 0
None
Universal Trial Number (UTN)
U1111-1236-0193
Trial acronym
CUPS (Cross-curricular Unit on Portion Size)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Portion size estimation skills 313465 0
Nutrition knowledge 313466 0
Childhood overweight and/or obesity 313539 0
Condition category
Condition code
Public Health 311893 311893 0 0
Health promotion/education
Diet and Nutrition 311969 311969 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This cluster randomised controlled trial will investigate the efficacy of a teaching unit integrating nutrition and mathematics in primary school children (CUPS). The goal of the CUPS program is to improve primary school children's portion size estimation skills and nutritional knowledge.

This teaching unit will specifically focus on the learning of appropriate portion sizes for each food group and the mathematical concept of volume and capacity. Fake food models, math cubes and measuring cups will be used to teach these two topics. Teaching unit content will be based on the NSW k-6 syllabus and Australian Guide to Healthy Eating. Experienced primary school teachers and researchers in the field of Nutrition and Education developed the lessons involved in this intervention.

Schools will be randomly allocated to either the intervention or control group for the study duration. Teachers in the intervention group will be invited for a one-day information session and will be provided with the teaching guidelines and materials. This day will be accredited with the NSW Education Standards Authority (NESA) as professional development towards maintaining their proficiency status. Members of the research team will deliver this information at the University of Newcastle. The control group will receive the workshop and resources on the completion of the program.

The teaching unit consists of 4-5 lessons of 40 minutes each which will be delivered over 1-4 weeks. Based on their usual teaching structure, teachers in the intervention group will be asked to plan when they will use the resource material during their classes. As these teachers have to align this with teaching the mathematics curriculum about “Understanding units of Measurement; volume and capacity”, they will be able to choose when to start with the teaching unit and within what time frame this will be delivered (1-4 weeks). The lessons will be provided to the students by the classroom teacher during regular teaching time at the primary schools.

The following research methodologies will be used:

Portion size estimation skills: will be assessed by determining the ability of a student to estimate the correct portion size of a given food. Math cubes will be used by the children to measure food volume of a set of food models.

Nutrition knowledge: will be determined by using a nutrition knowledge survey of 60 multiple-choice questions specifically designed for this study. Six domains will be covered to examine nutrition knowledge including healthy choices, portion/serve sizes and balanced meals, nutritional values, food groups, food safety and labels, and food sources.

Attitude towards mathematics: will be assessed using the “How I Feel About Maths Scale” (HIFAMS) by Chapman (2003).

Teaching quality: will be measured by coding either the intervention or usual lesson on volume and capacity. The Quality Teaching Lesson Observation Scales (NSW) will be used for these coding sessions.

Teacher interviews: will be held to report on the process evaluation. Semi-structured interviews with teachers from the intervention group will focus on the program perceptions, barriers and facilitators of the intervention implementation and delivery.

Student focus groups: will be conducted to explore students' perceptions of the CUPS program (intervention group only).
Intervention code [1] 314867 0
Prevention
Comparator / control treatment
Wait list control: classes allocated to the usual teaching group will not receive the CUPS program during the study period. However, the program resources will be delivered to these classes at the completion of the study (after school Term 1 2020).

Teachers in the usual classroom teaching group will be asked to continue their usual mathematics lessons on volume and capacity. Similarly to the intervention group, teachers in this group will be asked to inform the research team on their planning of teaching about volume and capacity.
Control group
Active

Outcomes
Primary outcome [1] 320560 0
Portion size estimation skills: will be assessed by determining the ability of a student to estimate the correct portion size of a given food. Math cubes will be used by the children to measure food volume of a set of food models. Students have to compare the volume of both items to estimate the number of cubes that correspond with the food volume. They will also be asked to report the food volume using other units of measurements (e.g. how many serves).
Timepoint [1] 320560 0
This outcome measure will be taken at three school visits; prior to commencement of the teaching unit or usual lessons (baseline visit), after the last lesson (follow-up visit 1), 4 weeks after follow-up visit 1 (follow-up visit 2). Time between data collection at baseline and follow-up visit 1 might differ per school as teachers are able to decide when to teach the lessons across 1-4 weeks.
Secondary outcome [1] 372008 0
Nutrition knowledge determined by using a nutrition knowledge survey of 60 multiple-choice questions specifically designed for this study. Six domains will be covered to examine nutrition knowledge including healthy choices, portion/serve sizes and balanced meals, nutritional values, food groups, food safety and labels, and food sources.
Timepoint [1] 372008 0
This outcome measure will be taken at three school visits; prior to commencement of the teaching unit or usual lessons (baseline visit), after the last lesson (follow-up visit 1), 4 weeks after follow-up visit 1 (follow-up visit 2). Time between data collection at baseline and follow-up visit 1 might differ per school as teachers are able to decide when to teach the lessons across 1-4 weeks.
Secondary outcome [2] 372033 0
Attitude towards mathematics will be assessed using the “How I Feel About Maths Scale” (HIFAMS) by Chapman (2003). This scale has ten statements on different aspects of mathematics attitudes (e.g. I like maths, Maths is an important subject). Students will rate their agreement for each statement on a five-point Likert scale ranging from strongly agree to strongly disagree. The HIFAMS has specifically been designed for primary school children as it is a short test using simple wording.
Timepoint [2] 372033 0
This outcome measure will be taken at three school visits; prior to commencement of the teaching unit or usual lessons (baseline visit), after the last lesson (follow-up visit 1), 4 weeks after follow-up visit 1 (follow-up visit 2). Time between data collection at baseline and follow-up visit 1 might differ per school as teachers are able to decide when to teach the lessons across 1-4 weeks.
Secondary outcome [3] 372037 0
Teaching quality will be measured by coding either the intervention or usual lesson on volume and capacity. The Quality Teaching Lesson Observation Scales (NSW) evaluate teaching behaviour divided into three dimensions including intellectual quality, quality learning environment and significance of learning. Each dimension is subdivided into six elements (descriptive statements) which will be rated on a likert scale ranging from 1 to 5. All coding will be performed by an experienced member of the research team.
Timepoint [3] 372037 0
A random selection of teachers will be involved in this outcome measure. Three teachers from each study arm will be observed for four lessons which will be scheduled according to the teachers' timeline.
Secondary outcome [4] 372038 0
Teacher interviews will be held to report on the process evaluation. Semi-structured interviews with teachers from the intervention group will focus on the program perceptions, barriers and facilitators of the intervention implementation and delivery. Questions from previous studies by Miller et al. (2015) and Riley et al. (2017) will be adjusted to match this intervention.
Timepoint [4] 372038 0
Each interview will take approximately 1 hour and will be conducted after the last lesson (follow-up visit 1).
Secondary outcome [5] 372235 0
Student focus groups will be conducted to explore students' perceptions of the CUPS program (intervention group only). This methodology has been used previously in a similar study by Riley et al. (2017) from which we will adapt the focus group questions.
Timepoint [5] 372235 0
This outcome measure will be taken once after the last lesson (follow-up visit 1) at the school.

Eligibility
Key inclusion criteria
Stage 2 Primary School Children (Year 3 and 4) and their teachers
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Class groups in which a teacher considers all nutritional and volume capacity content covered will be excluded. In addition, teachers with formal nutrition training/professional certification in nutrition or dietetics will be ineligible.

All students from consenting teachers will participate in the CUPS program and assessment activities. However, only data from students who return their consent letters will be used.

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was conducted to determine the sample size necessary to detect changes in portion size estimation (% deviance from actual). Based on proportional error reported when using an international food unit (Bucher et al., 2017), detection of a 5% reduction in error was regarded as clinically important. A sample size of 84 was needed to detect a 5% reduction in portion size estimation error (From 20% to 15%) assuming an alpha of 0.05 and power of 80%. To adjust for clustering, the following correction factor was applied [1+ (m – 1) x ICC] (Donner & Klar, 2000), where m = students per school and ICC = the intra-class correlation coefficient (between school variance / (between school variance + within school variance). Assumptions are based on clustering at the school level (one class recruited per school, with 25 students per class), and an ICC of 0.1 based on data from a large scale study in Australian schools (Lamb & Fullarton, 2001), resulting in a correction factor of 3.4. The resulting student sample is 285 students at 12 schools for a minimum detectable effect size of d = 0.62.
With on average 25 students per class, a sample size of 285 children divided by 25 results in 11,4 classes. This number was then rounded up to 12 classes. All students from each class will be invited to participate in the study meaning a total of 300 students will be recruited. The remaining 12 participants are the teachers involved in the study.

This study has been designed to obtain both qualitative and quantitative data. The Statistical Package for Social Sciences (SPSS) 24 will be used for all analyses. Descriptive statistics will be explored for the variables including means, medians, standard deviations, quartiles, percentages etc. Data will be checked for normality. Differences in quantitative outcomes will be analysed over time and between groups using linear mixed models. An alpha level of p<0.05 will be used as a cut-off for statistical significance. Qualitative data from the interviews and focus groups will be transcribed and analysed using a thematic approach.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/08/2019
Actual
23/10/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
23/10/2019
Date of last data collection
Anticipated
10/04/2020
Actual
17/12/2019
Sample size
Target
312
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303148 0
University
Name [1] 303148 0
University of Newcastle
Country [1] 303148 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
The University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 303145 0
None
Name [1] 303145 0
Address [1] 303145 0
Country [1] 303145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303698 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 303698 0
Ethics committee country [1] 303698 0
Australia
Date submitted for ethics approval [1] 303698 0
29/05/2019
Approval date [1] 303698 0
27/06/2019
Ethics approval number [1] 303698 0
H-2018-0492

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

Contacts
Principal investigator
Name 94530 0
Ms Berit Follong
Address 94530 0
HA06
University of Newcastle
School of Health Sciences
Callaghan Campus
University Drive
Callaghan NSW 2308
Country 94530 0
Australia
Phone 94530 0
+61 0249854316
Fax 94530 0
Email 94530 0
[email protected]
Contact person for public queries
Name 94531 0
Berit Follong
Address 94531 0
HA06
University of Newcastle
School of Health Sciences
Callaghan Campus
University Drive
Callaghan NSW 2308
Country 94531 0
Australia
Phone 94531 0
+61 0249854316
Fax 94531 0
Email 94531 0
[email protected]
Contact person for scientific queries
Name 94532 0
Berit Follong
Address 94532 0
HA06
University of Newcastle
School of Health Sciences
Callaghan Campus
University Drive
Callaghan NSW 2308
Country 94532 0
Australia
Phone 94532 0
+61 0249854316
Fax 94532 0
Email 94532 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


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
SourceTitleYear of PublicationDOI
EmbaseIntegrating nutrition into the mathematics curriculum in Australian primary schools: protocol for a randomised controlled trial.2020https://dx.doi.org/10.1186/s12937-020-00640-x
N.B. These documents automatically identified may not have been verified by the study sponsor.