Clinical trial NCT06234111: Semaglutide and Physical Activity for Obesity and Multimorbidity
Official title: Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity Morbid
Multimorbidity
Obesity
Keywords: Obesity
Multimorbidity
Semaglutide
Glucagon-like peptide-1 receptor agonist
Physical activity
Exercise
Co-design
Patient-centred
Cardiometabolic health
Health-related quality of life
Wegovy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals living in the Capital Region of Denmark can be referred to the weight loss program if they fulfill the Danish criteria for bariatric surgery while having comorbidities that increase the risk of surgery or challenge the accompanying necessary lifestyle changes, thereby making them ineligible for bariatric surgery. Consequently, most patients in the weight loss program are severely burdened by high levels of obesity (usually BMI \&gt; 40 kg/m2) and have debilitating somatic and mental multimorbidity (corresponding to Edmonton Obesity Staging System stages 2-4). In other words, patients for whom a substantial and sustained weight loss is expected to lead to tangible and significant health benefits.

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.

Eligibility 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.

Primary outcomes:
measure: Habitual physical activity
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Secondary outcomes:
measure: Health-related quality of life: physical
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: 10-years cardiovascular risk (previous cardiovascular disease)
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
measure: 10-years cardiovascular risk (type 2 diabetes)
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
measure: 10-years cardiovascular risk (apparently healthy)
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
Other outcomes:
measure: Body weight
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Waist circumference
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Health-related quality of life: mental
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Weight bias internalization
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Cardiorespiratory fitness
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Lower body strength
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
measure: Walking capacity and endurance
timeFrame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
state: Capital Region
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Rasmus H Brødsgaard, MSc
role: PRINCIPAL_INVESTIGATOR
References: