ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620000996965

Ethics application status

Approved

Date submitted

28/07/2020

Date registered

6/10/2020

Date last updated

6/10/2020

Date data sharing statement initially provided

6/10/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Younger Women's Wellness Program for Premenstrual Syndrome in University students

Scientific title

Feasibility of a multimodal health behaviour change intervention program for Premenstrual Syndrome in University students.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Premenstrual Syndrome

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A sequential mixed method approach will explore the feasibility of a health intervention to treat Premenstrual symptoms in female students aged 18-35 years. The first phase includes a pilot randomized controlled trial (RCT) among Australian university students who will be allocated at random to one of three groups. Group 1 will receive either the Younger Women’s Wellness Program (YWWP) and access to the Smartphone Application, Group 2 will receive access to the Smartphone Application only and Group 3 will receive access to YWWP only.

Group 1: Younger Women’s Wellness Program + Smartphone Application – Participants will receive health education material, including a Program Journal Book PDF copy or a hardcopy book – the participant would be given a choice for their preferred mode of delivery.
The Younger Women’s Wellness Program book forms the foundation of the intervention. The book is divided into 4 Steps with 3 weeks in each Step:

• Step 1: Changing your lifestyle and learning about health (Week 1-3);
• Step 2: Consolidating a healthy lifestyle and learning more about your health (Week 4-6);
• Step 3: Maintaining a healthy lifestyle and health promotion for illness prevention (Week 7- 9), and;
• Step 4: Becoming independent (Week 10-12).

Over the 12 week time frame, the book provides a step by step guide to promote healthy lifestyle behaviours with a particular emphasis on regular exercise and healthy eating. On every day of the first three weeks, new information and activities are provided. This first three weeks is designed to provide the foundation for the rest of the program, providing structure and detailed information for participants. In the remaining nine weeks, weekly information is provided about a range of health topics including: exercises; stress management; sleep; healthy weight. Throughout the book there is a balance of information about various health topics, suggested activities and goal setting. The journal/book has been designed for this study and will encourage the participant to bring together the various components of the health education provided and incorporate it into their life over a 12-week period. The journal includes a weekly planner, where participants are encouraged to plan their exercise for the following week. At regular intervals throughout the program, participants are encouraged to reflect on how well they are meeting the exercise and other goals they have set and to acknowledge positive behaviour change they have made. For example, Week 6 is titled ‘Reflection and transformation week’ with participants being invited to review all the lifestyle changes they have made, reward themselves for positive change and to reflect and write down what they would like to improve.
Supporting the information in the book are a series of fact sheets that cover specific topics in the book in greater depth. The topics covered in the fact sheets include – eating for PMS, body composition and health, goal setting for wellness, mindfulness and so on.

The participants will also receive access to a smartphone application, Clue- Period and cycle tracker. The participants can enter their menstrual cycle dates and symptoms on the smartphone application at their discretion.

Group 2: Smartphone Application
Smartphone Application- The participants will receive access to a smartphone application, Clue- Period and cycle tracker. The participants can enter their menstrual cycle dates and symptoms on the smartphone application at their discretion.

Group 3: Younger Women’s Wellness Program
Participants in Group 3 will receive the PDF copy of the book or the hardcopy hard copy book/Journal along with fact sheets and resources.

All the participants will receive a phone call on week 6 by the researcher to make sure they don’t have any difficulties accessing the program and if they are able to follow the instructions in the program.

Phase two: Phase two of this study will include semi-structured interviews and thematic analysis to gain an in-depth understanding of their perceptions of the acceptability, appropriateness, usefulness and sustainability of intervention and its components (Group 1 participants only).
Participants in group 1 will be contacted after the 12-week study for an in-depth semi-structured interview.
The aim of the interviews is to understand in-depth the interventional components that were helpful for women and those that were not. Further information will also be elicited from informants about the content and delivery methods that are likely to yield maximum likelihood of participant retention.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

Group 2: Smartphone Application
Smartphone Application- The participants will receive access to a smartphone application, Clue- Period and cycle tracker. The participants can enter their menstrual cycle dates and symptoms on the smartphone application at their discretion.

Control group

Active

Outcomes

Primary outcome [1]

The primary objective of phase one of this study is to demonstrate the feasibility of conducting a powered trial to evaluate the intervention. The following feasibility parameters will be examined:
(i) eligibility (=75% of potential participants screened will meet inclusion criteria),
(ii) recruitment (=70% of eligible participants consent to enrol into the study),
(iii) protocol adherence (=80% of participants in intervention arm will adhere to the program),
(iv) retention (=85% of participants will complete all follow-up assessments)
(v) missing data (=10% of data are missing).

Timepoint [1]

An online survey will be sent out to all the participants at 12 weeks post enrolment (t2)

Primary outcome [2]

The following feasibility parameters will be examined in phase two (semi-structured interviews) of the study:
(i) protocol adherence (=80% of participants will adhere to the program),
(ii) acceptability and satisfaction (=80% of participants will report satisfaction and acceptability of the program)

Timepoint [2]

Semi-structured interviews will be conducted within four weeks after completing the week-12 survey (Group 1 only).

Secondary outcome [1]

Premenstrual symptoms will be assessed by PSST (Premenstrual Symptoms Screening Tool)

Timepoint [1]

On enrolment (T1), 12 weeks post enrolment (T2)

The participants will fill the questionnaires at the same time points including: baseline (on enrolment-T1) and after completing the 12-week program (T2)

Secondary outcome [2]

General Self-Efficacy will be measured using the General self-efficacy tool (GSE)

Timepoint [2]

Secondary outcome [3]

Sleep will be assessed using the GSDS (General Sleep Disturbance Scale)

Timepoint [3]

Secondary outcome [4]

Physical activity will be assessed through IPAQ-SF (Physical activity-International Physical Activity Questionnaire- Short form)

Timepoint [4]

Secondary outcome [5]

Functional health and well-being will be assessed using the SF-12 questionnaire

Timepoint [5]

Secondary outcome [6]

The semi-structured interviews will provide an in-depth understanding of the elements of the intervention and those that need modification.

Timepoint [6]

Semi-structured interviews will be conducted within four weeks after completing the week-12 survey (Group 1 only).

Eligibility

Key inclusion criteria

The Inclusion criteria for the study:
• Female University students who experience some PMS symptoms of feeling sad, tearful, irritable, angry, anxious or depressed a week before the menstrual cycle
• Age between 18-35 years
• Women who have a regular menstrual cycle (last 3 cycles)
• Basic computer literacy
• Access to smartphone

Minimum age

18 Years

Maximum age

35 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria:
• Self-reported chronic conditions or disease or injury preventing vigorous exercise.
• Self-reported current mental health problem preventing commitment to a 12-week lifestyle program

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

A central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated, stratified random number table

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1 / Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

This feasibilty study is not powered to evaluate efficacy, nor is there a true control group.
However descriptive and inferential statistical analysis will be undertaken preliminary measures of efficacy and to inform sample size calculations and study design of future larger study.

Statistical data for phase will be analyzed using Statistical Package for the Social Sciences (SPSS)®. Descriptive statistics will be expressed as counts and percentages and mean (SD) for normally distributed data. Bivariate associations will be analysed using one-way Analysis of Variance (ANOVA) and Pearson’s correlation for linear relationships between normally distributed continuous variables.

Qualitative data (semi-structured interviews) will be audio recorded and transcribed prior to analysis. The transcribed data will undergo thematic analysis using Braun and Clarke’s six phases to thematic analysis. Once the initial codes are generated, they will be grouped like ideas and patterns. Codes will generate concept formation and themes can be identified. Themes will then be reviewed and after discussion with the project team and a report will be generated.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

6/01/2020

Date of last participant enrolment

Anticipated

23/11/2020

Actual

Date of last data collection

Anticipated

4/03/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

Logan Campus, Griffith University,
Meadowbrook,
QLD 4131

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Logan Campus, Griffith University,
Meadowbrook,
QLD 4131

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Nathan Campus, Griffith University
 Queensland 4222

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/07/2018

Approval date [1]

29/08/2018

Ethics approval number [1]

2018/705

Summary

Brief summary

The study aims to explore the feasibility and acceptability of the younger women’s wellness program for PMS in University students .In Phase one, Feasibility will be determined through composite analysis of eligibility, recruitment, retention, protocol adherence, missing data, and sample size estimates.
In phase two, participants in group 1 will be contacted after completing the 12-week study for an in-depth semi-structured interview (30-40 minutes). The aim of Phase two qualitative study is to understand in-depth the interventional components that were helpful for women and those that were not. Further information will also be elicited from informants about the content and delivery methods that are likely to yield maximum likelihood of participant retention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Gayatri Marwah

Address

Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131

Country

Australia

Phone

+61 469289372

Fax

[email protected]

Contact person for public queries

Name

Gayatri Marwah

Address

Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131

Country

Australia

Phone

+61 469289372

Fax

[email protected]

Contact person for scientific queries

Name

Gayatri Marwah

Address

Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131

Country

Australia

Phone

+61 469289372

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

Sharing participant data in a public forum is not included in the ethics approval.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8622	Informed consent form					380282-(Uploaded-28-07-2020-14-55-09)-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	Feasibility of a multiple health behavior change program for premenstrual symptoms in university students: A study protocol.	2021	https://dx.doi.org/10.1016/j.eujim.2021.101399

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

Trial Review

Documents added manually

Documents added automatically