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Trial registered on ANZCTR


Registration number
ACTRN12620000231943
Ethics application status
Approved
Date submitted
19/01/2020
Date registered
25/02/2020
Date last updated
25/02/2020
Date data sharing statement initially provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effects of an educational intervention to improve high school students’ ability to understand and critically appraise health claims.
Scientific title
Assessing the effects of an educational intervention to improve high school students' ability to understand and critically appraise health claims: a pilot cluster randomised trial
Secondary ID [1] 300191 0
None
Universal Trial Number (UTN)
U1111-1246-0913
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health education 315748 0
Condition category
Condition code
Public Health 314029 314029 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health HACC (How to Assess Claims Critically) is a four-module education program which has been developed based on key concepts considered necessary to be able to critically assess health claims (developed through an international consensus project), a qualitative study to explore students’ current understanding of health claims and decisions, and from gaps in existing interventions identified through a systematic review of studies evaluating educational interventions designed to improve these skills.
When and how much: In total, the program’s duration is anticipated to be approximately 4 hours. The program is divided into 4 modules, each designed to take approximately one school lesson/period (approximately 50 minutes). The teacher can determine the most appropriate pace to move through the topics and the scheduling of the topics (such as the time between each module) using the estimated times as a guideline.
The approximate time between delivery of modules will be determined by the teacher delivering the intervention. We anticipate it is likely that teachers will choose to deliver the intervention in consecutive classes. It is likely that classes will occur at least once week, and some may be more often.
Module 1 introduces students to “health claims”, explaining how they can be identified and discussing the variable quality of health claims. Module 2 focuses on information and study types, which includes explaining the different types of health claims, discusses relevant concepts such as causation, conflicts of interest, bias, and how different types of scientific research are performed. Module 3 focuses on fair comparisons of health interventions, covering topics such as randomised controlled trials, placebos and how studies can make a ‘fair’ comparison of interventions. The final module, Module 4, is the culmination of the previous modules, and challenges students to critically assess health claims, think about what information would be reliable, and demonstrates how to make sense of the resulting numbers in studies and health claims.
Intervention materials have been specifically designed for this study and: include a teacher guide, student booklet, and PowerPoint slides. The teacher guide includes: 1) Introduction to the Health H.A.C.C. program, its purpose, and structure; 2) learning objectives for each module; 3) for each module, the procedure and key discussion points: topics to be discussed, reference to the relevant PowerPoint slides, discussion questions and references to activities to be completed within the student handbook, and other resources needed. The student booklet contains activities specific to each module. The PowerPoint slides are provided for ease of teacher delivery and contain the learning objectives, discussion questions, and activity instructions from the Teacher Guide.
Intervention provider and mode of delivery: Classroom teachers will deliver the educational intervention face-to-face to classes of students using the resources provided. Teachers will be advised that the researchers are available to be contacted at any point during the study for further information or support. The topics included within the intervention align most cogently with the concepts covered in science, health education (part of physical education) and media literacy (part of English). However, the background of the teachers involved and classrooms in which the modules are taught will be determined at the discretion of each school. The Teacher Guide contains a table that lists the Australian Curriculum, Assessment and Reporting Authority (ACARA) criteria which are covered by the Health HACC program.
When and how much: In total, the program’s duration is anticipated to be approximately 4 hours. The program is divided into 4 modules, each designed to take approximately one school lesson/period (approximately 50 minutes). The teacher can determine the most appropriate pace to move through the topics and the scheduling of the topics (such as the time between each module) using the estimated times as a guideline.
Intervention fidelity (including student adherence to the intervention) will not be measured formally, however teachers will be interviewed at the end of the trial and asked if all topics in the materials were covered.
Intervention code [1] 316467 0
Other interventions
Comparator / control treatment
Participating teachers in the schools that are assigned to the control groups will continue with usual teaching throughout the study. Once the post-intervention data collection has occurred, the schools in the control groups will be offered a copy of the Health H.A.C.C. materials so that they can choose to teach the program to students if they wish.
Control group
Active

Outcomes
Primary outcome [1] 322434 0
The Claim Evaluation Tool consists of multiple-choice questions which have been rigorously assessed and validated as a way to determine people’s ability to understand the identified Key Concepts required to critically assess health claims. Nineteen multiple choice questions from within the Claim database have been selected, based on their relevance to the topics covered within the Health H.A.C.C. program.
The primary outcome will be the between-group difference in the change score (from pre- to post-intervention) in the mean test score (number of correct answers). The total maximum score for the test, at each time, is 25.
Timepoint [1] 322434 0
Pre-intervention assessment
Students in both groups will self-complete, in class time, the Claim questionnaire.
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers in the intervention group will ask the students, at a time convenient to the class, to complete the same questionnaire as at pre-intervention. Teachers in schools allocated to the control group will be advised to ask students to complete the questionnaire approximately 8 weeks after it was first completed.
Secondary outcome [1] 378530 0
The between-group difference in the proportion of children with a mastery score on the Claim questionnaire (defined as score of > or = 20, out of 25), will be calculated. This scoring system is based on the cut-point used by the Informed Health Choices [IHC] study, in which they determined that a score of 20 out of 24 indicated mastery.

Timepoint [1] 378530 0
Pre-intervention assessment
Students in both groups will self-complete, in class time, the Claim questionnaire.
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers in the intervention group will ask the students, at a time convenient to the class, to complete the same questionnaire as at pre-intervention. Teachers in schools allocated to the control group will be advised to ask students to complete the questionnaire approximately 8 weeks after it was first completed.
Secondary outcome [2] 378531 0
Intended behaviours will be assessed: 3 questions, using a Likert scale response. These are based on the questions used in the Informed Health Choices trial.
Timepoint [2] 378531 0
(No pre-intervention assessment)
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers will ask the students, at a time convenient to the class, to complete these questions. Teachers in schools allocated to the control group will be advised to ask students to complete the questions approximately 8 weeks after they were first completed.
Secondary outcome [3] 378532 0
Self-efficacy will be assessed: 4 questions, using a Likert scale response. These are based on the questions used in the Informed Health Choices trial.
Timepoint [3] 378532 0
(No pre-intervention assessment)
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers will ask the students, at a time convenient to the class, to complete these questions. Teachers in schools allocated to the control group will be advised to ask students to complete the questions approximately 8 weeks after they were first completed.
Secondary outcome [4] 378533 0
Attitudes towards assessing claims will be assessed: 4 questions, using a Likert scale response. These are based the questions used in the Informed Health Choices trial.
Timepoint [4] 378533 0
(No pre-intervention assessment)
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers will ask the students, at a time convenient to the class, to complete these questions. Teachers in schools allocated to the control group will be advised to ask students to complete the questions approximately 8 weeks after they were first completed.
Secondary outcome [5] 378715 0
Satisfaction with the Health HACC intervention will be assessed (Intervention group only): 4 questions, using a Likert scale response. These are based the questions used in the Informed Health Choices trial.
Timepoint [5] 378715 0
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers will ask the students, at a time convenient to the class, to complete these questions. The students in schools allocated to the control group will not be answering these questions.
Secondary outcome [6] 379467 0
Health advertisement appraisal skills (Intervention group only): Students will be provided with a fictitious health advertisement that contains a health claim, followed by 5 short answer questions.
Timepoint [6] 379467 0
Post-intervention assessment
Within 4 weeks of teaching the final module, teachers will ask the students, at a time convenient to the class, to complete this assessment. The students in schools allocated to the control group will not be answering these questions.
Secondary outcome [7] 379468 0
Satisfaction (from the teachers’ perspective): Satisfaction with, and feedback about, the intervention will be assessed through brief interviews with participating teachers at intervention group schools.
Timepoint [7] 379468 0
Post-intervention assessment
Within 4 weeks of teaching the final module, at a time convenient to the teachers, a member of the research team will interview each teacher that delivered the intervention. Teachers in schools allocated to the control group will not be interviewed.
Secondary outcome [8] 379469 0
Feasibility of the intervention will be examined using process measures, obtained through the interview with the teachers, such as:
- how many classes taught all 4 modules of the Health H.A.C.C. program?
- how many classes taught at least 3 modules?
- how many classes attempted all the student activities?
- how many schools completed the program within the estimated time (4 hours)?
- how many schools completed the program, but required more time to teach the content?
Timepoint [8] 379469 0
Post-intervention assessment
Within 4 weeks of teaching the final module, at a time convenient to the teachers, a member of the research team will interview each teacher that delivered the intervention. Teachers in schools allocated to the control group will not be interviewed.

Eligibility
Key inclusion criteria
All students in Years 7, 8, and/or 9 from independent (private) high schools in Australia will be eligible to participate, along with students in Years 7, 8, and/or 9 from public high schools within Victoria and independent public high schools within Queensland. The year level/s and number of classes that participate will be at each school’s discretion (for example, the school may decide that only Year 7 students will participate, or that only two of the four Year 9 Science classes will participate). All teachers of eligible students are eligible to assist with delivering the intervention. Each school will determine the most appropriate classes to deliver the program. Teachers are not formally participating however, the teachers of the classes that are allocated to the intervention group in this study will deliver the intervention, and provide information about the feasibility of, and satisfaction with, the program.
Minimum age
12 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students in years other than 7-9 will be excluded from participating. We anticipate ages ranging from approximately 12-15 years. Schools that only provide education for students with disabilities or special needs, or for international students (from non-English speaking backgrounds) will not be eligible.

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)
Consenting schools will be randomly assigned to the intervention or control groups using a computer-generated randomisation schedule, by a researcher who is not a member of the research team, with equal numbers of the schools allocated to each group. A member of the research team will then advise schools of their allocation and manage distribution of the intervention materials.
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
Data will be analysis according to intention-to-treat principles. For each outcome, we will report the mean and standard deviation, or median and interquartile range, for each group, the estimated difference, the estimated 95% confidence interval for the difference and the p value. To analyse between-group differences for the primary and secondary outcomes, we will use mixed models with a random effects term for the clusters, using linear regression for continuous outcomes and logistic regression of dichotomous outcomes. For questions that assess knowledge or understanding, missing values will be counted as incorrect answers. For the questions about intended behaviours, self-efficacy, and satisfaction, we will dichotomise the responses (e.g. ‘very difficult’ and ‘difficult’ vs ‘easy’ and ‘very easy’) for analysis and report the proportions of students for each of the four response options.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 304624 0
University
Name [1] 304624 0
Bond University
Address [1] 304624 0
Bond University
14 University Drive, ROBINA QLD
4226 AUSTRALIA
Country [1] 304624 0
Australia
Primary sponsor type
Individual
Name
Leila Cusack
Address
c/o
Institute of Evidence-Based Healthcare
The Faculty of Health Sciences and Medicine
Bond University
14 University Drive, ROBINA QLD
4226 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 304918 0
None
Name [1] 304918 0
NA
Address [1] 304918 0
NA
Country [1] 304918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305044 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 305044 0
Bond University,
14 University Dr, Robina QLD 4226
Ethics committee country [1] 305044 0
Australia
Date submitted for ethics approval [1] 305044 0
Approval date [1] 305044 0
17/12/2019
Ethics approval number [1] 305044 0
LC01939
Ethics committee name [2] 305104 0
Research in Victorian Government Schools and/or Early Childhood Settings (RISEC)
Ethics committee address [2] 305104 0
Department of Education and Training Victoria
2 Treasury Place, East Melbourne.
GPO Box 4367
MELBOURNE, Victoria 3001
Ethics committee country [2] 305104 0
Australia
Date submitted for ethics approval [2] 305104 0
02/12/2019
Approval date [2] 305104 0
20/12/2019
Ethics approval number [2] 305104 0
2019_004234

Summary
Brief summary
Health information is easily accessible through the media and internet, and therefore people are more actively involved in the management of their own health. However, much of the available health information is of variable quality, and basing health decisions on unreliable information can be harmful to the person and a waste of healthcare services.
In this cluster randomised controlled trial, we aim to recruit approximately 12 schools. We will assess a brief educational intervention (approximately 4 hours in duration), specifically designed for this study, to teach Australian high school students in grades 7-9 (ages approximately 12-15 years) to be able to identify and evaluate claims about health interventions. This intervention aims to enhance students “critical thinking” skills about health information, which requires specific education.
The effect of this intervention on knowledge/understanding and skills will be assessed in a randomised comparison against no exposure to the intervention. It is anticipated that the intervention group students' ability to identify and analyse health claims will improve.
Trial website
Trial related presentations / publications
Public notes
Target number of schools is approximately 12 (randomisation is at school level).

Contacts
Principal investigator
Name 99086 0
Dr Leila Cusack
Address 99086 0
Institute for Evidence-Based Healthcare
Bond University Faculty of Health Sciences and Medicine, Building 5, Level 2
14 University Dr, Robina QLD 4226

Country 99086 0
Australia
Phone 99086 0
+617 5595 4482
Fax 99086 0
Email 99086 0
leila.cusack@student.bond.edu.au
Contact person for public queries
Name 99087 0
Dr Leila Cusack
Address 99087 0
Institute for Evidence-Based Healthcare
Bond University Faculty of Health Sciences and Medicine, Building 5, Level 2
14 University Dr, Robina QLD 4226

Country 99087 0
Australia
Phone 99087 0
+617 5595 4482
Fax 99087 0
Email 99087 0
leila.cusack@student.bond.edu.au
Contact person for scientific queries
Name 99088 0
Dr Leila Cusack
Address 99088 0
Institute for Evidence-Based Healthcare
Bond University Faculty of Health Sciences and Medicine, Building 5, Level 2
14 University Dr, Robina QLD 4226

Country 99088 0
Australia
Phone 99088 0
+617 5595 4482
Fax 99088 0
Email 99088 0
leila.cusack@student.bond.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?
Claim questionnaire results
When will data be available (start and end dates)?
Following publication, no end date formally determined at this stage.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
The data will be available upon request through the first author and/or via the Institute of Evidence-Based Healthcare: leila.cusack@student.bond.edu.au, https://iebh.bond.edu.au/.
What supporting documents are/will be available?
No other documents available
Summary results
No Results