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

NCT06800560 | Completed

• 1 other identifier: MenoScale Validation
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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).

Conditions

Menopause

Keywords

Menopause; Questionnaire Validation; Perimenopause; Postmenopause; Quality of Life; Diet Quality; Menopausal Symptoms

Outcome Measures

Primary Outcomes (1)

• MenoScale validity for menopause symptoms

  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 Outcomes (3)

• MenoScale validity for quality of life

  Baseline

• MenoScale reliability

  Baseline and 1 week later

• Diet quality

  Baseline

Study Arms (4)

PeriHRT - perimenopausal women currently using hormone replacement therapy

Sub-cohort

Other: MenoScale; Other: Greene Climacteric Scale; Other: RAND 36-Item Health Survey 1.0; Other: PREDICT-FFQ-v1

Peri - perimenopausal women not using hormone replacement therapy

Sub-cohort

Other: MenoScale; Other: Greene Climacteric Scale; Other: RAND 36-Item Health Survey 1.0; Other: PREDICT-FFQ-v1

PostHRT - postmenopausal women currently using hormone replacement therapy

Sub-cohort

Other: MenoScale; Other: Greene Climacteric Scale; Other: RAND 36-Item Health Survey 1.0; Other: PREDICT-FFQ-v1

Post - postmenopausal women not using hormone replacement therapy

Sub-cohort

Other: MenoScale; Other: Greene Climacteric Scale; Other: RAND 36-Item Health Survey 1.0; Other: PREDICT-FFQ-v1

Interventions

MenoScale OTHER

Menopause symptom questionnaire

Peri - perimenopausal women not using hormone replacement therapy; PeriHRT - perimenopausal women currently using hormone replacement therapy; Post - postmenopausal women not using hormone replacement therapy; PostHRT - postmenopausal women currently using hormone replacement therapy

Greene Climacteric Scale OTHER

Menopause symptom questionnaire

Peri - perimenopausal women not using hormone replacement therapy; PeriHRT - perimenopausal women currently using hormone replacement therapy; Post - postmenopausal women not using hormone replacement therapy; PostHRT - postmenopausal women currently using hormone replacement therapy

RAND 36-Item Health Survey 1.0 OTHER

Quality of life questionnaire

Also known as: Short Form 36, SF36, SF-36

Peri - perimenopausal women not using hormone replacement therapy; PeriHRT - perimenopausal women currently using hormone replacement therapy; Post - postmenopausal women not using hormone replacement therapy; PostHRT - postmenopausal women currently using hormone replacement therapy

PREDICT-FFQ-v1 OTHER

Food frequency questionnaire

Also known as: Food frequency questionnaire, FFQ

Peri - perimenopausal women not using hormone replacement therapy; PeriHRT - perimenopausal women currently using hormone replacement therapy; Post - postmenopausal women not using hormone replacement therapy; PostHRT - postmenopausal women currently using hormone replacement therapy

Eligibility Criteria

• Age: 37 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoe Global Limited: lead

Study Sites (1)

ZOE Ltd

London, United Kingdom

Location

Related Publications (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. Epub 2023 Dec 21.

  PMID: 38171939 BACKGROUND

• Bermingham KM, Linenberg I, Hall WL, Kade 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. Epub 2022 Oct 18.

  PMID: 36270905 BACKGROUND

Related Links

• Menopause transition: effects on women's economic participation

Study Officials

• Sarah Berry, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 30, 2025
• Study Start: November 12, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 17, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)