NCT06234111

Semaglutide and Physical Activity for Obesity and Multimorbidity

Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity Morbid
• Multimorbidity
• Obesity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Semaglutide 2.4 mg, total diet replacement, behavioural intervention	Patients receive a highly specialized interdisciplinary weight loss treatment comprising two phases. Firstly, they engage in a total diet replacement using Nupo for approximately three months to induce a maximal weight loss. After this and for the duration of the entire treatment period, patients receive Semaglutide 2.4 mg and behavioural dietary support to maintain the weight loss and improve health. The total treatment period is two years.

Timeline

• Start date: 2024-02-20
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2024-01-31
• Last updated: 2024-12-12

Locations

1 site across 1 country: Denmark