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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Change in Menopause Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
Participants in the control group will not have access to the MELOW app during the study period
MELOW
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.
干预措施: MELOW (Behavioral)
结局指标
主要结局
Change in Menopause Rating Scale
时间窗: Change in Menopause Rating Scale from enrolment to 6 month mark
Change in Menopause Rating Scale (MRS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Jocelyn Chew
Assistant Professor, Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore (NUS)
National University Health System, Singapore