Multimorbidity, Obesity, Obesity Morbid
Conditions
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
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.
Interventions
COMBINATION_PRODUCTSemaglutide 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.
Sponsors
Hvidovre University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Habitual physical activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life: physical | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | The 36-Item Short Form Survey (SF-36) questionaire will be administered for all patients. The physical component summary score and its associated domain scores (physical functioning, role-physical, bodily pain, general health) will be presented as the mean change between baseline, four months, and follow-up scores. Possible scores range from 0 to 100, with higher scores indicating better health status. |
| 10-years cardiovascular risk (previous cardiovascular disease) | Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks). | The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the SMART risk assessment tool. This specific risk assessment tool will be used only for individuals with previous cardiovascular disease, as it was designed for this particular population. All data needed for the SMART risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up. |
| 10-years cardiovascular risk (type 2 diabetes) | Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks). | The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the ADVANCE risk assessment tool. This specific risk assessment tool will be used for individuals with type 2 diabetes and without previous cardiovascular disease, as it was designed for this particular population. All data needed for the ADVANCE risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up. |
| 10-years cardiovascular risk (apparently healthy) | Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks). | The 10-years risk of myocardial infarction, stroke or cardiovascular death wil be calculated using the SCORE2 risk assessment tool. This specific risk assessment tool will be used for individuals without type 2 diabetes and previous cardiovascular disease, as it was designed for this particular population. All data needed for the SCORE2 risk assessment tool are already being collected as routine practice. Results derived from the three different risk assessment tools will be combined, as they measure the exact same outcome (10-years cardiovascular risk). They will be presented as mean change in absolute risk between baseline, four months, and follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lower body strength | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | Lower body strength and endurance will be measured with the 30-Seconds Sit-To-Stand test and will be presented as mean change in repetitions between baseline, four months, and follow-up. |
| Body weight | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | The patients' body weight will be measured and presented as mean percentual change in weight between baseline, four months, and follow-up. |
| Walking capacity and endurance | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | Walking capacity and endurance will be measured with the 6-Minute Walk Test and will be presented as mean change in meters walked between baseline, four months, and follow-up. |
| Waist circumference | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | Waist circumference will be measured in cm with 1 decimal with a tape measurer and presented as mean change between baseline, four months, and follow-up. |
| Health-related quality of life: mental | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | The 36-Item Short Form Survey (SF-36) questionaire will be administered for all patients. The mental component summary score and its associated domain scores (vitality, social functioning, role-emotional, mental health) will be presented as the mean change between baseline, four months, and follow-up scores. Possible scores range from 0 to 100, with higher scores indicating better health status. |
| Weight bias internalization | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | The Weight Bias Internalization Scale (WBIS) will be administered for all patients. The WBIS includes 19-items to be rated on a 7-point Likert scale ranging from strongly disagree to strongly agree. The mean score of all 19 items will be calculated and presented as mean change between baseline, four months, and follow-up. Possible mean scores range from 1 to 7, with higher scores indicating greater weight bias internalization. |
| Cardiorespiratory fitness | Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks). | Maximal oxygen uptake (VO2max) will be measured with the Seismofit System. The Seismofit sensor is placed on the sternum, where it measures seismocardiography (the vibrations generated by the heart and transmitted through the chest). These measures are coupled with information on sex, age, weight, and height. Using an algorithm, the Seismofit System then estimates VO2max. Change in VO2max will be presented as mean change between baseline, four months, and follow-up. |
Countries
Denmark
Outcome results
None listed