Advancing Precision Medicine for Cardiovascular Disease and Diabetes in Asian Populations: Digital Intervention Cohort (COBRA+)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of participants having sufficient physical activity
研究概览
简要总结
The overarching aim is to improve cardiometabolic health and promote healthy ageing by supporting adults to adopt favourable lifestyle patterns identified through our observational research. The trial will recruit n=600 to be involved in Phase I (referred to as the "Optimisation Phase") of a two-phase project (Phase II trial registration will be submitted separately). All participants will complete a baseline study visit where, after consent taking, will complete a baseline questionnaire, receive a smartwatch each and additional wearables if applicable, and download the study app for the receiving and testing of interventions and completion of short form surveys. Participants will be involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months. Consenting participants may also be contacted to participate in interviews to be involved in the co-design of interventions, or to provide insights to the feasibility and process evaluation of the trial.
详细描述
The study adopts a hybrid design among free-living participants, combining an observational study phase with intervention development, testing, optimisation, and evaluation. The trial will recruit n=600 in Phase I (referred to as the "Optimisation Phase"). Optimisation Phase participants are involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months.
Participants who are eligible and interested will complete the consent taking, questionnaire, administration of devices (and instructions for removal, where applicable), and app onboarding for COBRA+ study (also known as The Healthy Habits Study).
Consent taking (taken face to face and recorded and acknowledged electronically), questionnaire, administration of devices (and instructions for removal, where applicable), and app onboarding would be completed in 2 to 3 hours. Informed consent to participate in the present study will be obtained in a private space. Self-administered questionnaires on personal characteristics and cognitions including personality, habit strength, screen use, typical social and environmental contexts for eating and physical activity, subjective health status, psychosocial and quality of life, work productivity and activity impairment, and healthcare use will be administered.
Continuous glucose monitoring (CGM): All participants who do not have a known sensitivity to medical-grade adhesives or a bleeding disorder will be fitted with a CGM sensor (BUZUD CGM 2.0 sensor) on the upper part of their non-dominant arm during the study visit, which they will wear continuously for up to 15 days at a time. These participants will be required to download the BUZUD application ("app") and scan their sensor at least once a day, to share their data with the research team over the study period. They will also receive up to three CGM sensors and applicators in batches (during the in-person visit or via tracked mail) for remote self-administration over the study period. A research team member will remain contactable to provide technical advice, and participants will be offered the option to have the sensor applied by the study operations team at the study site. The CGM product is designed to be minimally invasive, comfortable, and supports self-application; product information for the CGM sensor has been supplemented under the 'Use of Devices' section. Research/operations team may reach out to the participants to verify that the remote application has been administered correctly to avoid fraudulence. Participants will be provided with information on who to contact in the event of experiencing bruising, discomfort, and/or inconvenience when wearing the sensor, and will be directed to contact the operations team via telephone or email to discuss.
Smartwatch: All participants will receive a Garmin vivoactive 5 smartwatch to be worn daily over the 12-month study period, and download the Garmin Connect app to support data sharing with the research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are currently enrolled in the Singapore Population Health Studies - Multi-Ethnic Cohort Phase 3 (MEC3) or Second Follow-up (F2),
- •are of Chinese, Malay, or Indian ethnicity,
- •are 21 to 69 years old, and
- •can read and write English,
- •own or use a smartphone (iOS ≥ 12.4 or Android ≥ 8 with at least 5 GB of free storage, and data plan and internet access),
- •are able and willing to download and use study smartphone apps,
- •are able and willing to wear the smartwatch provided throughout the study period, and
- •can walk independently.
排除标准
- •have a history or current condition of stroke, heart attack, kidney failure, diabetes mellitus, thyroid disease, or cancer, or have had a vascular bypass surgery or angioplasty procedure (either stent or balloon) performed, or
- •a serious mental health condition including schizophrenia, psychotic depression, or severe dementia, or
- •are currently pregnant or planning to get pregnant during the study period, or
- •are participating or planning to participate in other lifestyle intervention studies.
- •have a known sensitivity to medical-grade adhesives or a bleeding disorder will be [applicable to continuous glucose monitoring component only]
- •with contraindications specified by the blood pressure monitoring device manufacturer [applicable to continuous blood pressure monitoring component only]
- •participated in the pilot study [applicable to main trial only].
结局指标
主要结局
Number of participants having sufficient physical activity
时间窗: At baseline, and every 5 weeks, up to 52 weeks from joining the study
Based on self-report and devices
Number of participants having sufficient sleep
时间窗: At baseline, and every 5 weeks, up to 52 weeks from joining the study
Based on self-report and devices
Number of participants meeting dietary guidelines
时间窗: At baseline, and every 5 weeks, up to 52 weeks from joining the study
Based on self-report
次要结局
- Glycaemic response(Up to 3 assessments in total, each assessment lasting 2 weeks, with all assessments completed within 52 weeks from joining the study)
研究者
Dr Falk Mueller-Riemenschneider
Associate Professor
National University of Singapore