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.
