Semaglutide and Physical Activity for Obesity and Multimorbidity

Hvidovre University Hospital

Status: Active, not recruiting

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 and exclusion criteria

Study participants are recruited from a particular interdisciplinary weight loss program based at Copenhagen University Hospital Hvidovre. Hence, the study uses the same set of inclusion criteria:

Inclusion criteria:

• Fulfilment of the Danish criteria for bariatric surgery:
• BMI ≥ 35 kg/m2
• Aged ≥ 18 years
• One or more obesity-related conditions (type II diabetes, resistant hypertension, sleep apnea, severe osteoarthritis of the lower extremities)
• One more comorbidities that prevent bariatric surgery

Exclusion criteria are:

• Unwillingness to participate in the study
• Inability to understand Danish
• Cognitive impairments

UPDATE 17.09.2024:

After initiating patient recruitment for the study on 15.02.2024, the project group identified discrepancies between the eligibility criteria and description of the study population as originally reported in the trial registration and those actually applied in the study. As a result, we adjusted both the eligibility criteria and description of the study population in the trial registration on 17.09.2024. These adjustments do not represent a change in the actual patient population but rather offer a more accurate and consistent description of their characteristics.

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