Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Habitual physical activity
研究概览
简要总结
The aim of this observational study is to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing during interdisciplinary Semaglutide-based weight loss treatment in patients with severe obesity and multimorbidity.
This study is explorative and therefore does not include hypothesis testing.
详细描述
This study is part of the project "Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare".
While this observational quantitative study aims to provide a comprehensive description of changes in patients' health and wellbeing during and after participation in weight loss treatment, the project also includes a qualitative interview study with a subset of patients from the same population to supplement and expand upon the quantitative findings. Additionally, a smaller subgroup of patients from the same population will eventually be invited to actively contribute to the collaborative development of a physical activity intervention in a co-design process, drawing on insights from the aforementioned studies.
Given its exploratory approach, the study is designed with a flat non-hierarchical outcome structure and multiple evenly valued outcomes measures. This will be reported evenly for all outputs of this research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Habitual physical activity
时间窗: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
SENS Motion accelerometry will be used to measure habitual physical activity, defined as time spent non-sedentary and not lying down. We will measure for seven full days. Data will be presented as mean change in hours/day spent physically active between baseline, four months, and follow-up. As mentioned, the study is exploratory and designed with a flat outcome hierarchy and multiple evenly valued outcome measures. The registration template requires that one outcome is listed as "primary", which is why this one is listed. This does not mean we consider this outcome more important than other outcomes.
次要结局
- 10-years cardiovascular risk (previous cardiovascular disease)(Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).)
- 10-years cardiovascular risk (type 2 diabetes)(Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).)
- Health-related quality of life: physical(Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).)
- 10-years cardiovascular risk (apparently healthy)(Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).)
研究者
Rasmus Hoxer Brødsgaard
Principal Investigator
Hvidovre University Hospital