Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001486516
Ethics application status
Approved
Date submitted
29/11/2024
Date registered
19/12/2024
Date last updated
19/12/2024
Date data sharing statement initially provided
19/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing public health professionals' social media competency for effective health promotion, communication and advocacy
Scientific title
Addressing public health professionals' social media competency for effective health promotion, communication and advocacy through a massive open online course
Secondary ID [1] 313442 0
Healthway [grant no. 34516]
Universal Trial Number (UTN)
U1111-1313-3662
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public health 335826 0
Condition category
Condition code
Public Health 332399 332399 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Item 1. Brief name: A Massive Open Online Course: Using Social Media for Effective Health Promotion, Communication and Advocacy

Item 2. Why: The online tailored intervention will be evaluated using a waitlist control methodology throughout 2025, with participants randomised to the intervention group (early start) or the waitlist control (delayed start). The MOOC adheres to the xMOOC pedagogy, rooted in cognitive-behavioural science with an emphasis on individual learning and knowledge transfer (i.e. between educator and learner). This approach predominantly employs brief, lecture-style videos complemented by readings, problem-solving scenarios, quizzes, and assignments.

Item 3. What (materials): Enrolled participants will complete the MOOC (Using Social Media for Effective Health Promotion, Communication and Advocacy) which comprises 6 modules:
• Module 1: Exploring the Commercial Determinants and their Impact on Health
• Module 2: Social Media Essentials
• Module 3: Using Social Media for Public Health Education and Advocacy
• Module 4: Health Promotion Message Framing and Values
• Module 5: Futureproofing: Managing and Responding to Opposition, Trolls and Misinformation
• Module 6: The Future of Health Promotion on Social Media

Participants’ will work through the MOOC at their own pace over 10 weeks from their course commencement date. Participants will have access to supplementary readings and learning materials, interactive learning activities, a discussion board and end-of-module quizzes.

Item 4. What (procedures): This study will use convenience sampling to recruit Australian-based health promotion and public health professionals via professional public health and health promotion associations and organisations. These entities will disseminate recruitment materials to their members and employees via a variety of communication methods, including email, newsletters and social media. Interested individuals will be directed to complete an expression of interest form via Qualtrics, which the research team will use to determine eligibility for participation.

Eligible and enrolled participants will complete online Qualtrics surveys at three time points: (T0) baseline, prior to randomisation to the intervention or wait-list; (T1) interim post-test at week 10 allowing time for the early start group to complete the intervention considering work commitments; and (T2) final post-test at week 24 allowing ten weeks for the delayed start group to complete the intervention.

Item 5. Who provided: The MOOC will be delivered through the Curtin University edX platform (https://www.edx.org/school/curtinx). Five content experts were involved in creating the MOOC.

Item 6. How: Enrolled participants (n=228) will complete the MOOC online. The intervention will be delivered in two groups: Early start (intervention) (n=114) and delayed start (waitlist control) (n=114). Participants will regularly receive emails, notifying them of their course commence date, encouraging them to complete modules, and reminding them to complete surveys.

Item 7. Where: The intervention is delivered to individuals online and therefore participants can choose where they complete it.

Item 8. When and how much: The MOOC contains 6 modules, and each module is anticipated to take participants 1-3 hours to complete. The early start group will first receive the intervention, followed by the delayed start group. Each group will have up to 10 weeks to complete the intervention.

Item 9. Tailoring: Not applicable.

Item 10. Modifications: Not applicable currently.

Item 11. How well (planned): Drawing on approaches used in previous MOOC evaluation studies (1, 2), we will use a framework that integrates two established models – the RE-AIM (3) and Kirkpatrick (4) models – to evaluate the MOOC. For the present study, we selected specific dimensions from both the RE-AIM and Kirkpatrick models deemed most relevant and applicable – Efficacy (the short-term impact of the intervention on key outcomes), Reach (the participation rate within the target population and participant characteristics), Reaction (participants’ responses to the intervention), Learning (the extent to which participants acquire the intended knowledge and confidence), Maintenance (the sustainability of the program over time), and Behaviour (the degree to which knowledge is applied in practice).

A process evaluation will be undertaken throughout the intervention to determine reach (attendance); fidelity (quality of intervention, intervention delivery and resources), together with recruitment, and dose delivered and received (5). Criteria for assessing programme quality will take into account: i) utility: information needs of participants are satisfied, e.g. usefulness of resources; ii) propriety: ethical standards are met, e.g. aggregated evaluation findings are made accessible to participants; and iii) accuracy: valid and reliable information, e.g. clear and accurate report documentation (6).

Face-to-face, online, structured exit interviews (approximately n=16) will be conducted with MOOC completers (n=4) and non-completers (n=4) from the early start group at week 10; and with MOOC completers from the early start group at week 24 (n=4) and the delayed start group (n=4) at week 36. These interviews will provide insight into intervention implementation and factors that influence participation and delivery.

edX Insights will be used to monitor adherence to the intervention. The available data are presented in three sections:
1. Who are my learners? (Enrolment details – includes how many learners plus demographics (e.g. education level, gender, and geographic location));
2. What are learners engaging with in my course (Engagement details – includes weekly totals for active learners; how many watched a video, tried a problem, and participated in discussions);
3. How well is my content supporting learners? (Performance details – average grades assessments, and for ungraded problems).

Item 12. How well (actual): Not applicable currently.

References
1. Smith-Lickess SK, Woodhead T, Burhouse A, Vasilakis C. Study design and protocol for a comprehensive evaluation of a UK massive open online course (MOOC) on quality improvement in healthcare. BMJ Open. 2019;9(12):e031973.
2. Meinert E, Alturkistani A, Brindley D, Carter A, Wells G, Car J. Protocol for a mixed-methods evaluation of a massive open online course on real world evidence. BMJ Open. 2018;8(8):e025188.
3. Glasgow R, Vogt T, Boles S. Evaluating the public health impact of health promotion interventions: The RE-AIM framework. Am J Public Health. 1999;89(9):1322-7.
4. Kirkpatrick D. Great ideas revisited: revisiting Kirkpatrick's four-level model. Training and Development. 1996;50:54-9.
5. Bauman A, Nutbeam D. Evaluation in a nutshell: A practical guide to the evaluation of health promotion programs. Sydney: McGraw Hill; 2013.
6. Yarbrough D, Shulha L, Hopson R, Caruthers F. The program evaluation standards: A guide for evaluators and evaluation users. 3rd ed. Thousand Oaks: SAGE; 2011.
Intervention code [1] 330014 0
Prevention
Comparator / control treatment
Individuals will be recruited and screened for eligibility. Once eligibility is confirmed, participants will enrol in the MOOC. Enrolled participants will complete baseline measures and then be randomised to receive the intervention in one of two groups: early start (intervention; Group A) and delayed start (waitlist control; Group B). For the purposes of this project, Group B is the waitlist group and will therefore act as the control group as per a waitlist design. Group B will start the intervention at week 14. Although participants will not be blinded to group allocation, they will be asked not to discuss the content of the MOOC with colleagues to mitigate the risk of study contamination bias.

Data collection will occur throughout 2025 and across three time points:
1. (T0) baseline: All participants will receive the baseline survey prior to randomisation to the intervention (Group A) or wait-list (Group B);
2. (T1) interim post-test: Groups A and B will receive the interim post-test at week 10; and
3. (T2) final post-test: Groups A and B will receive the final post-test at week 24.
Control group
Active

Outcomes
Primary outcome [1] 339959 0
Any change in overall social media context awareness as a tool for health promotion.
Timepoint [1] 339959 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period).
Secondary outcome [1] 442088 0
Any change in social media competency as tool for health promotion.
Timepoint [1] 442088 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period) .
Secondary outcome [2] 442398 0
Any impact on professional practice as a result of completing intervention module/s.
Timepoint [2] 442398 0
T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period),
Secondary outcome [3] 442985 0
Any change in social media communication process understanding as a tool for health promotion.
Timepoint [3] 442985 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period).
Secondary outcome [4] 442984 0
Any change in social media literacy as a tool for health promotion.
Timepoint [4] 442984 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period).
Secondary outcome [5] 442986 0
Any change in social media content impact awareness as a tool for health promotion.
Timepoint [5] 442986 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period).
Secondary outcome [6] 442987 0
Any change in social media confidence as a tool for health promotion.
Timepoint [6] 442987 0
T0 (baseline), T1 (week 10 post-Group A intervention period), and T2 (week 24 post-Group A intervention period).

Eligibility
Key inclusion criteria
The inclusion criteria are as follows: a) participants must be aged 18 years or older; b) reside in Australia; c) be employed as a health promotion and/or public health professional; and d) must have no conflict of interest with any parties involved in the production, distribution or sale of tobacco, nicotine or vaping products, ultra-processed food or drink, arms or pharmaceuticals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are as follows: a) under 18 years of age; b) residing outside of Australia; c) not employed as a health promotion and/or public health professional; and d) identified conflict of interest with any parties involved in the production, distribution or sale of tobacco, nicotine or vaping products, ultra-processed food or drink, arms or pharmaceuticals.

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 is concealed - central randomisation by computer.
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
Wait-list controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic characteristics of the participants will be described using frequency and percentage, by group. To evaluate the program, the effect of the MOOC on participant's SMCA scores at different time intervals during the follow-up period will be assessed using random effect regression models. Likewise, the impact of the MOOC on the secondary outcome SMCI will also be analysed using random effect regression models. Subsequent secondary outcomes related to the impact on professional practice will also be compared between groups. All statistical analyses will be performed using Stata IC/18. The significance level will be set at 0.05. Open text responses will be collated and analysed thematically using NVivo v14.

In alignment with the gold standard methodology outlined by the CONSORT statement, analyses will be performed on an intention-to-treat basis. The intention-to-treat analysis will encompass all participants according to their assigned intervention, irrespective of their completion of the intervention. Complete case analyses will be performed when imputation of missing data is not feasible.

Exit interviews will be audio recorded with the participant's permission and transcribed verbatim by an independent transcription service within two weeks of interview completion. Qualitative data will be collated and analysed thematically using NVivo v14. Data will be reported according to the standards for reporting qualitative research (SRQR) guidelines.

Results of the evaluation will be reported according to the CONSORT guidelines and TIDieR.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317881 0
Government body
Name [1] 317881 0
Healthway
Country [1] 317881 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 320218 0
None
Name [1] 320218 0
Address [1] 320218 0
Country [1] 320218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316566 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 316566 0
Ethics committee country [1] 316566 0
Australia
Date submitted for ethics approval [1] 316566 0
08/12/2022
Approval date [1] 316566 0
19/01/2023
Ethics approval number [1] 316566 0
HRE2023-0020

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

Contacts
Principal investigator
Name 138266 0
Prof Jonine Jancey
Address 138266 0
School of Population Health, Curtin University, Kent Street, Bentley, Western Australia, Australia 6102
Country 138266 0
Australia
Phone 138266 0
+61 8 9266 3807
Fax 138266 0
Email 138266 0
[email protected]
Contact person for public queries
Name 138267 0
Jonine Jancey
Address 138267 0
School of Population Health, Curtin University, Kent Street, Bentley, Western Australia, Australia 6102
Country 138267 0
Australia
Phone 138267 0
+61 8 9266 3807
Fax 138267 0
Email 138267 0
[email protected]
Contact person for scientific queries
Name 138268 0
Jonine Jancey
Address 138268 0
School of Population Health, Curtin University, Kent Street, Bentley, Western Australia, Australia 6102
Country 138268 0
Australia
Phone 138268 0
+61 8 9266 3807
Fax 138268 0
Email 138268 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethics approval has not been obtained for IPD release.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Low Risk Approved.pdf


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.