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

January 23, 2025 updated by: Zoe Global Limited

Validating a Novel Instrument Developed by ZOE Ltd. to Measure Menopause-related Symptoms and Quality of Life

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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]

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants for this study will be recruited from the ZOE Health Study, which is a community science app in which participants are actively involved in logging lifestyle and health data, and those who have consented to receiving the ZOE newsletter.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PeriHRT - perimenopausal women currently using hormone replacement therapy
Sub-cohort
Other: MenoScale
Menopause symptom questionnaire
Other: Greene Climacteric Scale
Menopause symptom questionnaire
Other: RAND 36-Item Health Survey 1.0
Quality of life questionnaire
Other Names:
  • SF36
  • SF-36
  • Short Form 36
Other: PREDICT-FFQ-v1
Food frequency questionnaire
Other Names:
  • Food frequency questionnaire
  • FFQ
Peri - perimenopausal women not using hormone replacement therapy
Sub-cohort
Other: MenoScale
Menopause symptom questionnaire
Other: Greene Climacteric Scale
Menopause symptom questionnaire
Other: RAND 36-Item Health Survey 1.0
Quality of life questionnaire
Other Names:
  • SF36
  • SF-36
  • Short Form 36
Other: PREDICT-FFQ-v1
Food frequency questionnaire
Other Names:
  • Food frequency questionnaire
  • FFQ
PostHRT - postmenopausal women currently using hormone replacement therapy
Sub-cohort
Other: MenoScale
Menopause symptom questionnaire
Other: Greene Climacteric Scale
Menopause symptom questionnaire
Other: RAND 36-Item Health Survey 1.0
Quality of life questionnaire
Other Names:
  • SF36
  • SF-36
  • Short Form 36
Other: PREDICT-FFQ-v1
Food frequency questionnaire
Other Names:
  • Food frequency questionnaire
  • FFQ
Post - postmenopausal women not using hormone replacement therapy
Sub-cohort
Other: MenoScale
Menopause symptom questionnaire
Other: Greene Climacteric Scale
Menopause symptom questionnaire
Other: RAND 36-Item Health Survey 1.0
Quality of life questionnaire
Other Names:
  • SF36
  • SF-36
  • Short Form 36
Other: PREDICT-FFQ-v1
Food frequency questionnaire
Other Names:
  • Food frequency questionnaire
  • FFQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MenoScale validity for menopause symptoms
Time Frame: Baseline
The ability of the MenoScale to measure the prevalence of menopause-related symptoms in comparison to the most widely-used scale in clinical practice.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MenoScale validity for quality of life
Time Frame: Baseline
- The ability of the MenoScale to measure the impact that symptoms have on overall quality of life in comparison to a widely-used quality of life scale.
Baseline
MenoScale reliability
Time Frame: Baseline and 1 week later
The reliability of the MenoScale to be repeated and how this compares to the Green Climacteric Scale
Baseline and 1 week later
Diet quality
Time Frame: Baseline
Associations between healthy dietary patterns, food groups and menopausal symptoms
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoe Global Limited

Investigators

  • Principal Investigator: Sarah Berry, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Actual)

December 11, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MenoScale Validation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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