MenopauseMELOWNCT07713862
Midlife Empowerment and Longevity Through Optimizing Wellness
A study testing MELOW in people with Menopause, run by National University Health System, Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- MELOW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Enhancing Healthy Longevity in At-Risk Midlife Women With Abdominal Obesity: A Digital Phenotyping Commitment Device on Improving Visceral Body Fat Mass, Menopausal Symptoms and Cardiometabolic Risk Factors
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:
Read more
- Can personalised lifestyle recommendations informed by wearable devices, dietary logging, and self-reported symptoms improve adherence to healthy diet, physical activity, and sleep behaviours?
- How are menopausal symptoms associated with changes in cardiometabolic health, body composition, physical function, and quality of life over time?
Participants will:
- Attend study visits at the National University of Singapore for health assessments, including measurements of body composition, physical function, and cardiometabolic health.
- Wear a smartwatch or wearable device to monitor physiological and activity data throughout the study.
- Use a mobile application to record dietary intake, menopausal symptoms, and other health-related information.
- Receive personalised lifestyle recommendations based on their health data and engage in regular follow-up assessments over the study period.
Read the detailed description
The Midlife Empowerment and Longevity through Optimizing Wellness (MELOW) study is a 12-month, two-arm, parallel-group, stratified randomized controlled trial designed to evaluate the effectiveness of a personalized digital lifestyle intervention for improving menopausal symptoms, lifestyle behaviours, and cardiometabolic health among perimenopausal women.
The primary objective of the study is to determine whether a personalized digital lifestyle intervention improves menopausal symptoms and cardiometabolic health. Secondary objectives include evaluating changes in body composition, physical function, glucose regulation, cardiovascular risk markers, gut microbiome composition, lifestyle behaviours, sleep, psychological well-being, and health-related quality of life. The study will also evaluate participant engagement with the digital intervention and explore relationships between wearable-derived physiological data, behavioural patterns, and menopausal symptom trajectories over time.
Following eligibility screening and informed consent, participants will attend a baseline assessment at the National University of Singapore (NUS). Baseline assessments include collection of demographic information, medical history, medication use, lifestyle behaviours, and menopausal history. Participants will undergo comprehensive cardiometabolic assessments, including waist circumference, blood pressure, heart rate, body composition analysis, handgrip strength, physical function assessed using the Short Physical Performance Battery (SPPB), and cognitive function assessed using the Montreal Cognitive Assessment (MoCA). Fasting venous blood samples will be collected for the measurement of cardiometabolic biomarkers, including glucose and lipid profiles, and stool samples will be collected for gut microbiome analyses. Participants will also complete validated questionnaires assessing menopausal symptoms, dietary behaviours, physical activity, mood, anxiety, stress, sleep, eating behaviours, and health-related quality of life.
All participants will receive standardized educational materials on healthy lifestyle behaviours and menopause management. Participants will also be provided with a continuous glucose monitor (CGM) for 15 days and an Oura Ring to collect continuous physiological and behavioural data, including sleep, physical activity, heart rate, and glucose responses.
Following completion of baseline assessments, participants will be randomly assigned using stratified randomization in a 1:1 ratio to either the MELOW intervention group or the control group.
Participants assigned to the intervention group will receive access to the MELOW mobile application for 6 months. During onboarding, participants will complete a goal-setting exercise to establish personalized health goals and behavioural targets. Throughout the intervention period, participants will complete brief ecological momentary assessments (EMAs) at least three times daily to report current symptoms, mood, energy levels, appetite, and other health-related states. These participant-reported data will be integrated with data collected from the wearable devices to generate personalized just-in-time adaptive interventions (JITAIs), including tailored behavioural recommendations and supportive messages designed to promote healthy eating, physical activity, sleep, and symptom self-management. Participants will also have access to an individualized dashboard displaying longitudinal trends in behavioural, physiological, and symptom data. Automated reminders will be delivered if scheduled app check-ins are missed.
Participants assigned to the control group will not receive access to the MELOW mobile application or personalized digital intervention during the study period. They will continue to receive standard educational materials provided at baseline and will complete the same assessment schedule as the intervention group.
All participants will attend follow-up visits at 6 and 12 months after enrolment. Follow-up assessments will repeat the baseline cardiometabolic measurements, body composition analysis, physical function assessments, fasting blood collection, stool sample collection, and questionnaire administration to evaluate longitudinal changes in health outcomes.
With participants' separate consent, any remaining biological samples and de-identified study data may be stored for future research related to metabolic health, diabetes, cardiometabolic disease, menopause, and lifestyle interventions. All data and biological specimens will be managed in accordance with institutional policies and applicable data protection regulations. Clinically significant incidental findings identified during study assessments may be communicated to participants with advice to seek appropriate medical follow-up.
- Conditions
- Menopause
- Being tested
- MELOW
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELOWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MELOW |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in Menopause Rating Scale (MRS) score from enrolment to 6 month mark
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Chew, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713862
- Sponsor's protocol ID
- 2026-0508-APP1
- Acronym
- MELOW
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Healthy Longevity in At-Risk Midlife Women With Abdominal Obesity: A Digital Phenotyping Commitment Device on Improving Visceral Body Fat Mass, Menopausal Symptoms and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT07713862
- Acronym / sponsor ID
- MELOW / 2026-0508-APP1
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can personalised lifestyle recommendations informed by wearable devices, dietary logging, and self-reported symptoms improve adherence to healthy diet, physical activity, and sleep behaviours?
- How are menopausal symptoms associated with changes in cardiometabolic health, body composition, physical function, and quality of life over time?
Participants will:
- Attend study visits at the National University of Singapore for health assessments, including measurements of body composition, physical function, and cardiometabolic health.
- Wear a smartwatch or wearable device to monitor physiological and activity data throughout the study.
- Use a mobile application to record dietary intake, menopausal symptoms, and other health-related information.
- Receive personalised lifestyle recommendations based on their health data and engage in regular follow-up assessments over the study period.
Detailed description
The Midlife Empowerment and Longevity through Optimizing Wellness (MELOW) study is a 12-month, two-arm, parallel-group, stratified randomized controlled trial designed to evaluate the effectiveness of a personalized digital lifestyle intervention for improving menopausal symptoms, lifestyle behaviours, and cardiometabolic health among perimenopausal women.
The primary objective of the study is to determine whether a personalized digital lifestyle intervention improves menopausal symptoms and cardiometabolic health. Secondary objectives include evaluating changes in body composition, physical function, glucose regulation, cardiovascular risk markers, gut microbiome composition, lifestyle behaviours, sleep, psychological well-being, and health-related quality of life. The study will also evaluate participant engagement with the digital intervention and explore relationships between wearable-derived physiological data, behavioural patterns, and menopausal symptom trajectories over time.
Following eligibility screening and informed consent, participants will attend a baseline assessment at the National University of Singapore (NUS). Baseline assessments include collection of demographic information, medical history, medication use, lifestyle behaviours, and menopausal history. Participants will undergo comprehensive cardiometabolic assessments, including waist circumference, blood pressure, heart rate, body composition analysis, handgrip strength, physical function assessed using the Short Physical Performance Battery (SPPB), and cognitive function assessed using the Montreal Cognitive Assessment (MoCA). Fasting venous blood samples will be collected for the measurement of cardiometabolic biomarkers, including glucose and lipid profiles, and stool samples will be collected for gut microbiome analyses. Participants will also complete validated questionnaires assessing menopausal symptoms, dietary behaviours, physical activity, mood, anxiety, stress, sleep, eating behaviours, and health-related quality of life.
All participants will receive standardized educational materials on healthy lifestyle behaviours and menopause management. Participants will also be provided with a continuous glucose monitor (CGM) for 15 days and an Oura Ring to collect continuous physiological and behavioural data, including sleep, physical activity, heart rate, and glucose responses.
Following completion of baseline assessments, participants will be randomly assigned using stratified randomization in a 1:1 ratio to either the MELOW intervention group or the control group.
Participants assigned to the intervention group will receive access to the MELOW mobile application for 6 months. During onboarding, participants will complete a goal-setting exercise to establish personalized health goals and behavioural targets. Throughout the intervention period, participants will complete brief ecological momentary assessments (EMAs) at least three times daily to report current symptoms, mood, energy levels, appetite, and other health-related states. These participant-reported data will be integrated with data collected from the wearable devices to generate personalized just-in-time adaptive interventions (JITAIs), including tailored behavioural recommendations and supportive messages designed to promote healthy eating, physical activity, sleep, and symptom self-management. Participants will also have access to an individualized dashboard displaying longitudinal trends in behavioural, physiological, and symptom data. Automated reminders will be delivered if scheduled app check-ins are missed.
Participants assigned to the control group will not receive access to the MELOW mobile application or personalized digital intervention during the study period. They will continue to receive standard educational materials provided at baseline and will complete the same assessment schedule as the intervention group.
All participants will attend follow-up visits at 6 and 12 months after enrolment. Follow-up assessments will repeat the baseline cardiometabolic measurements, body composition analysis, physical function assessments, fasting blood collection, stool sample collection, and questionnaire administration to evaluate longitudinal changes in health outcomes.
With participants' separate consent, any remaining biological samples and de-identified study data may be stored for future research related to metabolic health, diabetes, cardiometabolic disease, menopause, and lifestyle interventions. All data and biological specimens will be managed in accordance with institutional policies and applicable data protection regulations. Clinically significant incidental findings identified during study assessments may be communicated to participants with advice to seek appropriate medical follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group will not have access to the MELOW app during the study period |
| MELOW | Experimental | Behavioral: MELOWParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELOWParticipants 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. | Behavioural | MELOW |
Primary outcome
Change in Menopause Rating Scale (MRS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MELOW in people with Menopause, run by National University Health System, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menopause Rating Scale (MRS) (time frame: Change in Menopause Rating Scale (MRS) score from enrolment to 6 month mark). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.