RecruitingPhase 2ACTRN12620000996965

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

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


Sponsor

Griffith University

Enrollment

60 participants

Start Date

Jan 6, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

Premenstrual syndrome (PMS) — the physical and emotional symptoms that occur in the week or two before a menstrual period — affects many women of reproductive age. Symptoms like mood swings, irritability, sadness, anxiety, bloating, and fatigue can significantly impact daily life, but many women don't access support because programs are not tailored to younger women or are hard to access. This study is testing the feasibility of a 12-week online wellness program specifically designed for female university students experiencing PMS symptoms. The program addresses lifestyle factors that can influence hormonal health and mood, including exercise, nutrition, sleep, and stress management. In the first phase, researchers assess whether the program can be delivered as planned and whether students will participate and stick with it. In the second phase, in-depth interviews explore what aspects were most helpful. You may be eligible if you are a female university student aged 18 to 35, experience premenstrual emotional symptoms (such as sadness, irritability, anxiety, or tearfulness) in the week before your period, have had a regular menstrual cycle over the last three cycles, have basic computer literacy, and have access to a smartphone. Women with chronic conditions preventing vigorous exercise or current mental health problems that would prevent engagement with a 12-week program are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

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

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ACTRN12620000996965


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