Semaglutide and Physical Activity for Obesity and Multimorbidity

Hvidovre University Hospital

Status: Enrolling

Conditions: Multimorbidity; Obesity; Obesity Morbid

Treatments: Combination Product: Semaglutide 2.4 mg, total diet replacement, behavioural intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06234111

F-23061071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 35

At least one of the following obesity-related comorbidities:

• Type II diabetes
• Resistant hypertension
• Sleep apnea
• Desire to become pregnant and fertility problems (in women only)
• Severe osteoarthritis of the lower extremities

At least one of the following contraindications for bariatric surgery:

• Substance abuse
• Eating disorder
• Developmental/cognitive disabilities where the patient is not expected to adhere to the necessary lifestyle changes after surgery
• Comorbidities that increase the risk associated with surgery
• Severe mental illness
• Inability to independently achieve an 8 % weight loss

Exclusion criteria

• Inability to give informed consent

Trial design

35 participants in 1 patient group

Patients with severe obesity and multimorbidity

Description:

Patients with morbid obesity (mainly class II and III) with multiple chronic conditions. Most patients are initially referred for bariatric surgery, but are deemed ineligible for various reasons (typically inability to independently induce weight loss, severe mental disease, eating disorder, and serious comorbidity).

Treatment:

Combination Product: Semaglutide 2.4 mg, total diet replacement, behavioural intervention