NCT07713862

Brief Summary

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. 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. 2.How are menopausal symptoms associated with changes in cardiometabolic health, body composition, physical function, and quality of life over time?
  3. 3.Attend study visits at the National University of Singapore for health assessments, including measurements of body composition, physical function, and cardiometabolic health.
  4. 4.Wear a smartwatch or wearable device to monitor physiological and activity data throughout the study.
  5. 5.Use a mobile application to record dietary intake, menopausal symptoms, and other health-related information.
  6. 6.Receive personalised lifestyle recommendations based on their health data and engage in regular follow-up assessments over the study period.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 15, 2026

Last Update Submit

July 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Menopause Rating Scale (MRS)

    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.

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

Study Arms (2)

Control

NO INTERVENTION

Participants in the control group will not have access to the MELOW app during the study period

MELOW

EXPERIMENTAL

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.

Behavioral: MELOW

Interventions

MELOWBEHAVIORAL

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.

MELOW

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore (NUS)

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

July 23, 2026

Record last verified: 2026-07