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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] 301905 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual Syndrome 318416 0
Condition category
Condition code
Reproductive Health and Childbirth 316424 316424 0 0
Other reproductive health and childbirth disorders
Public Health 316425 316425 0 0
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] 318190 0
Lifestyle
Intervention code [2] 318191 0
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] 324578 0
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] 324578 0
An online survey will be sent out to all the participants at 12 weeks post enrolment (t2)
Primary outcome [2] 325199 0
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] 325199 0
Semi-structured interviews will be conducted within four weeks after completing the week-12 survey (Group 1 only).
Secondary outcome [1] 385008 0
Premenstrual symptoms will be assessed by PSST (Premenstrual Symptoms Screening Tool)
Timepoint [1] 385008 0
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] 385009 0
General Self-Efficacy will be measured using the General self-efficacy tool (GSE)
Timepoint [2] 385009 0
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 [3] 385010 0
Sleep will be assessed using the GSDS (General Sleep Disturbance Scale)
Timepoint [3] 385010 0
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 [4] 385011 0
Physical activity will be assessed through IPAQ-SF (Physical activity-International Physical Activity Questionnaire- Short form)
Timepoint [4] 385011 0
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 [5] 385012 0
Functional health and well-being will be assessed using the SF-12 questionnaire
Timepoint [5] 385012 0
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 [6] 387160 0
The semi-structured interviews will provide an in-depth understanding of the elements of the intervention and those that need modification.
Timepoint [6] 387160 0
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?
No
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
60
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306319 0
University
Name [1] 306319 0
Griffith University
Country [1] 306319 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Logan Campus, Griffith University,
Meadowbrook,
QLD 4131
Country
Australia
Secondary sponsor category [1] 307085 0
None
Name [1] 307085 0
Address [1] 307085 0
Country [1] 307085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306532 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 306532 0
Nathan Campus, Griffith University
Queensland 4222
Ethics committee country [1] 306532 0
Australia
Date submitted for ethics approval [1] 306532 0
19/07/2018
Approval date [1] 306532 0
29/08/2018
Ethics approval number [1] 306532 0
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 104186 0
Ms Gayatri Marwah
Address 104186 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131
Country 104186 0
Australia
Phone 104186 0
+61 469289372
Fax 104186 0
Email 104186 0
gayatri.marwah@griffithuni.edu.au
Contact person for public queries
Name 104187 0
Gayatri Marwah
Address 104187 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131
Country 104187 0
Australia
Phone 104187 0
+61 469289372
Fax 104187 0
Email 104187 0
gayatri.marwah@griffithuni.edu.au
Contact person for scientific queries
Name 104188 0
Gayatri Marwah
Address 104188 0
Logan campus Griffith University
68 University Drive
MEADOWBROOK
QLD 4131
Country 104188 0
Australia
Phone 104188 0
+61 469289372
Fax 104188 0
Email 104188 0
gayatri.marwah@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
8622Informed 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
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a multiple health behavior change program for premenstrual symptoms in university students: A study protocol.2021https://dx.doi.org/10.1016/j.eujim.2021.101399
N.B. These documents automatically identified may not have been verified by the study sponsor.