Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity Morbid
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Habitual physical activity
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rasmus Hoxer Brødsgaard
Principal Investigator
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Habitual physical activity
Time Frame: 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.
Secondary Outcomes
- 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).)