Midlife Empowerment and Longevity Through Optimizing Wellness | NCT07713862

NCT07713862

Overview

NCT ID: NCT07713862
Lead Sponsor: National University Health System, SingaporeOTHER
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
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:

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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jan 2027Estimated
Primary Completion Date: Jan 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 200Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

ControlNo Intervention

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

MELOWExperimental

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