The Development, Validation and Application of a Novel Questionnaire Developed by ZOE Ltd Measuring Menopause Symptoms and Subjective Quality of Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-12

Study Completion Date

2024-12-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The MenoScale has been developed from the most common symptoms identified in over 70,000 women to reflect symptom prevalence and user-friendly terminology. It builds and improves on pre-existing scoring tools in four main ways. Firstly, the symptoms assessed are informed by prevalence, as identified from a large cohort. Secondly, the language used to ask about symptoms is modern and accessible as determined through qualitative user research. Thirdly, the impact on quality of life is assessed. Finally, it is already being offered online and completely open access.

The overall aim of this study is to validate the reliability and validity of the MenoScale as an instrument to measure menopausal symptoms and the related subjective impact on quality of life (QoL).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

NCT06975111

Menopause Menopause Hot Flashes Menopause Related Conditions +1 more

NOT_YET_RECRUITING PHASE2/PHASE3

A Randomized Controlled Trial of Menopausal Tool/App for Women

NCT06919887

Menopausal Symptoms Menopause Symptom Management

ENROLLING_BY_INVITATION NA

Effects of Menopause Hormonal Therapy and Selective Serotonin Reuptake Inhibitor on Cognition, Sexual Function and Quality of Life

NCT05050981

Menopause

COMPLETED

MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making

NCT05299983

Menopause Premenopause Postmenopause

COMPLETED NA

Symptom Monitoring and Menopausal Symptoms

NCT05603234

Menopause

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Menopause, a crucial phase in a woman's life, is the disappearance of menstruation for 12 months or longer due to depleted ovarian activity. On average, this stage accounts for over one-third of a woman's lifespan (1). In the United Kingdom (UK), the average age of menopause is 51 years, with the transitional period known as perimenopause occurring from around 45 years (2). As of 2017, there are 13 million menopausal women in the UK, with one third being aged 50 years and over in full time employment (3). It is crucial to have reliable and accessible methods for measuring and tracking symptoms in order to establish medical and lifestyle interventions which may aid in alleviating the burden of these symptoms.

All stages of menopause is accompanied by a wide variety of fluctuating symptoms and subjective experiences of women. Therefore, an online, validated questionnaire offers women the opportunity to monitor their symptoms in real- time which ultimately will: 1) raise awareness by increasing understanding around menopause; 2) empower women to track and manage their menopause themselves; and 3) facilitate conversations by providing data-backed insights to enhance discussions with healthcare providers.

The study has four main objectives:

1. Validate the ability of the MenoScale to measure the prevalence of menopause-related symptoms in comparison to the most widely-used scale in clinical practice.
2. Validate the ability of the MenoScale to measure the impact that symptoms have on overall QoL in comparison to a widely-used QoL scale.
3. Evaluate the test-retest reliability of the MenoScale.
4. Explore relationships between menopause-related symptoms and dietary intake.

RECRUITMENT: Potential participants will be recruited from those who are enrolled onto the ZOE Health Study as well as their friends and family. Potential participants will be contacted via email and provided with a Participant Information Sheet. Participants will be given a minimum of 24 hours after receiving the information sheet to decide whether they would like to take part in the study. Those that would like to take part in the study will be screened using an online form via a secure survey platform and eligible participants will then be asked to provide informed consent.

STUDY DESIGN: Once informed consent has been provided all participants will be asked to complete online versions of a demographics questionnaire (ethnicity, education level, menopause history \[age symptoms started, age of last period\], HRT usage \[type and time period taken\]), the MenoScale, Green Climacteric Scale, and the Short Form-36. Participants will also be asked to completed a food frequency questionnaire at baseline only. Participants will be contacted seven days later to repeat the same procedures - except for the demographics, health questionnaire and FFQ. Completion of all questionnaires is expected to take approximately 1 hour at baseline and 15 minutes at follow up.

Biological samples will not be collected in this study, nor will previously collected data be analysed.

The only primary data collection to occur during this study is the following:

* Menopause symptoms questionnaires: MenoScale and Green Climacteric Scale
* Quality of life questionnaire: Short Form 36
* Dietary questionnaire: Predict-Food Frequency Questionnaire-v1
* Demographics questionnaire: ethnicity, BMI, HRT usage, education

References:

1. Bermingham KM, Linenberg I, Hall WL, Kadé K, Franks PW, Davies R, Wolf J, Hadjigeorgiou G, Asnicar F, Segata N, Manson JE, Newson LR, Delahanty LM, Ordovas JM, Chan AT, Spector TD, Valdes AM, Berry SE. Menopause is associated with postprandial metabolism, metabolic health and lifestyle: The ZOE PREDICT study. EBioMedicine. 2022 Nov;85:104303. doi: 10.1016/j.ebiom.2022.104303.
2. Gatenby C, Simpson P. Menopause: Physiology, definitions, and symptoms. Best Pract Res Clin Endocrinol Metab. 2024 Jan;38(1):101855. doi: 10.1016/j.beem.2023.101855.
3. Menopause transition: effects on women's economic participation - GOV.UK \[https://www.gov.uk/government/publications/menopause-transition-effects-on-womens-economic-participation\]

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Food frequency questionnaire

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Short Form 36 SF36 SF-36 Food frequency questionnaire FFQ

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Female (sex assigned at birth) Aged 37 - 70 years Peri- or postmenopausal (self-reported)

Exclusion Criteria

Currently pregnant and/or lactating History of hysterectomy or oophorectomy History of treatment-induced menopause Body mass index of \< 18.5 Subject is taking \> 5 prescribed medications Subject is unable to provide informed consent online Subject is unable understand the participant information sheet Subject is unable to complete the questionnaires online

Minimum Eligible Age

37 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No