Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000031167
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
11/01/2019
Date last updated
16/01/2023
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of My Vital Cycles (a school-based Whole Person ovulatory-menstrual health literacy program for 13-16 year old females) in Perth Western Australia
Scientific title
A formative intervention research study to develop and trial a school-based “Whole Person ovulatory-menstrual (OM) health literacy program” for 13-16 year old (Year 9-10) females in Perth Western Australia.
Secondary ID [1] 296994 0
This research is supported by the Australian Commonwealth Government's "Research Training Program" number CHESSN8617438119
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual cycle 310960 0
Dysmenorrhoea 310961 0
Premenstrual syndrome 310962 0
Abnormal uterine bleeding 310963 0
Polycystic ovarian sydrome 310964 0
Health literacy 311003 0
Endometriosis 328709 0
Fertility 328710 0
Mood disturbances 328711 0
Condition category
Condition code
Public Health 309623 309623 0 0
Health promotion/education
Reproductive Health and Childbirth 309624 309624 0 0
Menstruation and menopause
Reproductive Health and Childbirth 309625 309625 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: My Vital Cycles (an ovulatory menstrual health literacy educational intervention)

The materials included workbooks, videos and the website www.myvitalcycles.com These were finalised prior to recruitment. No further changes were made to the program once recruitment had started and the trial was underway.

Staffing: Secondary School facilitator of reproductive health with 15 years' experience

Conduct of the classes: These were done face-to-face in the Health classes with the teacher and school healthcare professionals present.

Frequency:
- Program delivery will be once a week for one hour over 16 weeks. Topics covered include:
1. A Whole Person context
2. Knowing the cycle
3. Common cycle difficulties
4. Managing common cycle difficulties
5. Critical reasoning on cycle shame
6. Communicating to health care professionals (including medical students)

Location:
- Program delivery was classroom based in a secondary school during school hours
- Participants initiate one-on-one discussions with school healthcare professionals and the facilitator

Note:
- The intervention program was uniformly delivered to all participants. There were no changes once the trial began and recruitment was underway.
- adherence / fidelity assessment: this is formative research. COREQ is a checklist to report methods, findings, analysis and interpretation [Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19(6), 349-357.] Process evaluation measures will also be established to protect the intervention program integrity.

Improvements in participants' ovulatory menstrual health literacy was measured quantitatively with the ovulatory-menstrual health literacy questionnaire administered pre and post intervention.
Intervention code [1] 313267 0
Lifestyle
Intervention code [2] 313268 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318581 0
Changes in ovulatory-menstrual health literacy as measured by a validated ovulatory-menstrual health literacy questionnaire which was created before recruitment began
Timepoint [1] 318581 0
14 days post completion of intervention
Secondary outcome [1] 365433 0
Ovulatory menstrual knowledge as measured by a specifically designed questionnaire
Timepoint [1] 365433 0
14 days post completion of intervention
Secondary outcome [2] 365434 0
Ovulatory menstrual attitude as measured by a specifically designed questionnaire
Timepoint [2] 365434 0
14 days post delivery of intervention
Secondary outcome [3] 365435 0
Self perceived confidence to communicate ovulatory menstrual health as measured by a specifically designed questionnaire
Timepoint [3] 365435 0
14 days post delivery of intervention

Eligibility
Key inclusion criteria
Students who are enrolled in Grade 9 at the participating school and who have consented to particpate
Minimum age
13 Years
Maximum age
15 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male students

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2020
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
30/06/2022
Date of last data collection
Anticipated
Actual
6/12/2022
Sample size
Target
150
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301570 0
Government body
Name [1] 301570 0
Australian Government Research Training Program
Country [1] 301570 0
Australia
Funding source category [2] 312985 0
Charities/Societies/Foundations
Name [2] 312985 0
WAIER Fogarty Foundation
Country [2] 312985 0
Australia
Funding source category [3] 312986 0
University
Name [3] 312986 0
Curtin Medical School
Country [3] 312986 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Population Health
Kent Street
Perth WA 6102
Country
Australia
Secondary sponsor category [1] 301265 0
None
Name [1] 301265 0
Address [1] 301265 0
Country [1] 301265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302297 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302297 0
HREC
Kent Street
Perth WA 6102
Ethics committee country [1] 302297 0
Australia
Date submitted for ethics approval [1] 302297 0
16/01/2018
Approval date [1] 302297 0
14/03/2018
Ethics approval number [1] 302297 0
HREC2018-0101

Summary
Brief summary
This study aims to develop and trial an intervention to facilitate ovulatory menstrual (OM) health literacy among 13-16 year old adolescent girls. Based on a whole person framework, the intervention will integrate the spiritual, intellectual, social and emotional dimensions with the physical changes of the OM cycle. The intervention will be trialled with a convenience sample of 120-150 Year 9 female adolescents from a single-sex school. The study hypothesis is that the intervention will facilitate positive attitudes towards OM health and skills to monitor and self-report OM health for confident communication of the common OM disturbances.
Trial website
www.myvitalcycles.com
Trial related presentations / publications
Public notes
Development of the intervention will begin with a critical review of the literature. It will then progress to the use of a Delphi panel of experts and focus groups to sharpen the pedagogy of developing participants’ skills to chart their OM cycle patterns and guide their understanding of their health from a whole person perspective. A questionnaire will also be developed to evaluate the improvement of the adolescents' ovulatory menstrual health literacy post intervention.

Contacts
Principal investigator
Name 89738 0
Mrs Felicity Roux
Address 89738 0
Curtin University School of Population Health Kent Street Perth Western Australia WA 6102
Country 89738 0
Australia
Phone 89738 0
+61 8 9266 9266
Fax 89738 0
Email 89738 0
[email protected]
Contact person for public queries
Name 89739 0
Felicity Roux
Address 89739 0
Curtin University School of Population Health Kent Street Perth Western Australia WA 6102
Country 89739 0
Australia
Phone 89739 0
+61 8 9266 9266
Fax 89739 0
Email 89739 0
[email protected]
Contact person for scientific queries
Name 89740 0
Felicity Roux
Address 89740 0
Curtin University School of Population Health Kent Street Perth Western Australia WA 6102
Country 89740 0
Australia
Phone 89740 0
+61 8 9266 9266
Fax 89740 0
Email 89740 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
Condition of ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
965Ethical approval    376670-(Uploaded-08-01-2019-13-25-51)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDeveloping and trialling a school-based ovulatory-menstrual health literacy programme for adolescent girls: A quasi-experimental mixed-method protocol.2019https://dx.doi.org/10.1136/bmjopen-2018-023582
N.B. These documents automatically identified may not have been verified by the study sponsor.