Midlife Empowerment and Longevity Through Optimizing Wellness
ConditionMenopause
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorNational University Health System, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
MELOW
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: MELOWExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Change in Menopause Rating Scale (MRS) score from enrolment to 6 month markLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: