Clinical trial

Midlife Empowerment and Longevity Through Optimizing Wellness

Opening soon · Not applicable · 0 countries · Registry ID NCT07713862

Opening soonNot applicableInterventional

What this study is about

The goal of this observational longitudinal study is to understand how lifestyle behaviours, menopausal symptoms, and digital health data change over time in women experiencing perimenopause or menopause, and to evaluate whether a personalised digital health programme can support healthier lifestyle behaviours and improve cardiometabolic health. The main questions it aims to answer are: 1. Can personalised lifestyle recommendations informed by wearable devices, dietary logging, and self-reported symptoms improve adherence to healthy diet, physical activity, and sleep behaviours? 2. How are menopausal symptoms associated with changes in cardiometabolic health, body composition, physical function, and quality of life over time? Participants will: 1. Attend study visits at the National University of Singapore for health assessments, including measurements of body composition, physical function, and cardiometabolic health. 2. Wear a smartwatch or wearable device to monitor physiological and activity data throughout the study. 3. Use a mobile application to record dietary intake, menopausal symptoms, and other health-related information. 4. Receive personalised lifestyle recommendations based on their health data and engage in regular follow-up assessments over the study period.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years

SexFemale

Healthy volunteersNot accepted

ConditionMenopause

Full registry criteria

Inclusion Criteria: * Women aged 21-65 years old; * Report at least mild climacteric symptoms as indicated by an MRS score ≥5; * Waist circumference ≥80 cm, indicating abdominal adiposity; * Own and use a smartphone compatible with the CGM and Oura Ring. Exclusion Criteria: * Are currently receiving hormone replacement therapy (HRT); * Are currently using oral contraceptives; * Have been diagnosed with severe psychiatric illness requiring inpatient care; * Are concurrently enrolled in another behavioural or psychotherapy trial; * Have significant cognitive impairment or inability to engage with digital tools; * Have uncontrolled chronic medical conditions that may interfere with study participation; * Unable to comprehend written and spoken English.

Treatments and study arms

MELOW

Behavioral

Participants will be required to download and set up an app on your smartphone and complete a short health goal-setting exercise. They will be asked to respond to brief check-in questions through the app at least three times a day regarding energy levels, mood, appetite, and any symptoms such as hot flushes or sleep difficulties. Participant will then receive short personalised messages through the app based on wearables data and responses to support in managing symptoms and maintaining healthy habits. The app will send reminders if it receives no response to the prompts. They will also be able to view a personalised health dashboard on the app, updated regularly as device data syncs.

Primary outcomes

Change in Menopause Rating Scale (MRS)Change in Menopause Rating Scale (MRS) score from enrolment to 6 month mark

Menopause Rating Scale (MRS) is an 11-item questionnaire used to measure the severity of menopausal symptoms and the impact on quality of life. It evaluates 11 symptoms on a 0 to 4 scale, whereby 0 is 'No symptoms', 1 is 'Mild' 2 is 'Moderate', 3 is 'Severe', and 4 is 'Extremely severe'. The MRS score with a minimum score of 0 and maximum score of 44. The higher the score, the more severe the menopause symptoms.

Study locations

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No public site location was included in this record. Check the original registry for updates.