Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 7:10 PM
Study NCT ID:
NCT06800560
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development, Validation and Application of a Novel Questionnaire Developed by ZOE Ltd Measuring Menopause Symptoms and Subjective Quality of Life
Sponsor:
Zoe Global Limited
Organization:
Study Overview
Official Title:
Validating a Novel Instrument Developed by ZOE Ltd. to Measure Menopause-related Symptoms and Quality of Life
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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).
Detailed Description:
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 \[https://www.gov.uk/government/publications/menopause-transition-effects-on-womens-economic-participation\]
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 \[https://www.gov.uk/government/publications/menopause-transition-effects-on-womens-economic-participation\]
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: