24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Change in 24-hour movement composition from baseline over one year and two-year follow-up
研究概览
简要总结
A healthy lifestyle has proved beneficial health effects in managing type 2 diabetes mellitus (T2DM). Important lifestyle behaviors, i.e. sleep, sedentary time (SB), and physical activity (PA) subdivided into light physical activity (LPA) and moderate to vigorous physical activity (MVPA), have shown an impact on T2DM disease-specific characteristics (e.g. glycemic control). However, these behaviors have often been investigated separately. Therefore, a recent shift in research emphasizes the importance of considering these behaviors as part of a 24-hour day.
Since T2DM patients can benefit from an optimal 24-hour composition as part of a healthy lifestyle, it may be interesting to investigate the 24-hour movement composition among these T2DM patients over time. Moreover, exploring associations with different personal determinants, environmental determinants, and cardiometabolic markers will provide meaningful insights in developing recommendations and creating an intervention.
详细描述
The present study aims (1) to conduct a longitudinal observational study over two years to explore 24-hour movement behavior composition patterns among T2DM patients in comparison with a healthy control group and (2) to examine associations between these movement behaviors and personal and environmental determinants, and cardiometabolic markers. This study's primary endpoint is to develop insights into the 24-hour movement composition combined with T2DM patients' characteristics, determinants, and health profile to set the groundwork with the aim to develop, implement and evaluate an intervention in a future randomized controlled trial
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in 24-hour movement composition from baseline over one year and two-year follow-up
时间窗: The same primary outcome will be collected after two years
During their visit to Ghent University hospital, participants will receive a wGT3X-BT ActiGraph accelerometer that will objectively measure their 24-hour movement behaviors (PA, SB, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time. Furthermore, the individuals will subjectively report on their PA, SB, and sleep (duration and quality) through an online questionnaire based on international standardized PA (IPAQ), SB (SIT-Q-7d), and sleep questionnaires (Munich Chronotype questionnaire, Pittsburg sleep quality index, and Sleep Hygiene Index) (IPAQ, Sit-7Q, Munich Chronotype questionnaire, and Pittsburg sleep quality index, Sleep Hygiene Index). By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
次要结局
- Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up(The same secondary outcome will be collected after two years)
- Change in waist circumference from baseline to one and two-year follow-up(The same secondary outcome will be collected after two years)
- Change in HbA1c from baseline to two-year follow-up(The same secondary outcome will be collected after two years)
- Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up(The same secondary outcome will be collected after two years)
- Change in triglycerides from baseline to two-year follow-up(The same secondary outcome will be collected after two years)
- Change in Body Mass Index (BMI) from baseline to one and two-year follow-up(The same secondary outcome will be collected after two years)
- Change in insulin from baseline to two-year follow-up(The same secondary outcome will be collected after two years)
- Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up(The same secondary outcome will be collected after two years)
- Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up(The same secondary outcome will be collected after two years)
- Change in glucose from baseline to two-year follow-up(The same secondary outcome will be collected after two years)