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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]

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

Dysmenorrhoea

Premenstrual syndrome

Abnormal uterine bleeding

Polycystic ovarian sydrome

Health literacy

Endometriosis

Fertility

Mood disturbances

Condition category

Condition code

Public Health

Health promotion/education

Reproductive Health and Childbirth

Menstruation and menopause

Reproductive Health and Childbirth

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]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in ovulatory-menstrual health literacy as measured by a validated ovulatory-menstrual health literacy questionnaire which was created before recruitment began

Timepoint [1]

14 days post completion of intervention

Secondary outcome [1]

Ovulatory menstrual knowledge as measured by a specifically designed questionnaire

Timepoint [1]

14 days post completion of intervention

Secondary outcome [2]

Ovulatory menstrual attitude as measured by a specifically designed questionnaire

Timepoint [2]

14 days post delivery of intervention

Secondary outcome [3]

Self perceived confidence to communicate ovulatory menstrual health as measured by a specifically designed questionnaire

Timepoint [3]

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Research Training Program

Address [1]

Commonwealth Department of Education and Training
50 Marcus Clarke Street
Canberra
ACT 2600

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

WAIER Fogarty Foundation

Address [2]

PO Box 7875
Cloisters Square PO
Perth WA 6850

Country [2]

Australia

Funding source category [3]

University

Name [3]

Curtin Medical School

Address [3]

GPO Box U1987, Perth
Western Australia, 6845

Country [3]

Australia

Primary sponsor type

University

Name

Curtin University

Address

School of Population Health
Kent Street
Perth WA 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

HREC
Kent Street
Perth WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/01/2018

Approval date [1]

14/03/2018

Ethics approval number [1]

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

Mrs Felicity Roux

Address

Curtin University School of Population Health Kent Street Perth Western Australia WA 6102

Country

Australia

Phone

+61 8 9266 9266

Fax

[email protected]

Contact person for public queries

Name

Felicity Roux

Address

Curtin University School of Population Health Kent Street Perth Western Australia WA 6102

Country

Australia

Phone

+61 8 9266 9266

Fax

[email protected]

Contact person for scientific queries

Name

Felicity Roux

Address

Curtin University School of Population Health Kent Street Perth Western Australia WA 6102

Country

Australia

Phone

+61 8 9266 9266

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Condition of ethics approval

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
965	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Developing and trialling a school-based ovulatory-menstrual health literacy programme for adolescent girls: A quasi-experimental mixed-method protocol.	2019	https://dx.doi.org/10.1136/bmjopen-2018-023582

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically