Obesity MorbidNCT06234111
Semaglutide and Physical Activity for Obesity and Multimorbidity
An observational study of Obesity Morbid and Multimorbidity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Morbid, Multimorbidity, Obesity
- What is being tested?
- Semaglutide 2.4 mg, total diet replacement, behavioural intervention
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 \> 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Hvidovre
Hvidovre, Capital Region, 2650
About this study
Official title: Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare
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.
Read the 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
- Being tested
- Semaglutide 2.4 mg, total diet replacement, behavioural intervention
- 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
- Medical subject headings
- Obesity, Morbid, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mg, total diet replacement, behavioural interventionCombination product
Also called Wegovy, Nupo, Dietary counseling
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe obesity and multimorbidity | 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). Receives: Combination Product: Semaglutide 2.4 mg, total diet replacement, behavioural intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual physical activity
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.
Measured: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Secondary outcomes (4)
Health-related quality of life: physical
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.
Measured: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
10-years cardiovascular risk (previous cardiovascular disease)
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.
Measured: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
10-years cardiovascular risk (type 2 diabetes)
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.
Measured: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
10-years cardiovascular risk (apparently healthy)
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.
Measured: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start20 Feb 2024
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Hoxer Brødsgaard, Hvidovre University Hospital
- Investigators
- Rasmus H Brødsgaard, MSc, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234111
- Sponsor's protocol ID
- F-23061071
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare
- ClinicalTrials.gov ID
- NCT06234111
- Acronym / sponsor ID
- F-23061071
- Conditions
- Obesity Morbid, Multimorbidity, Obesity
- Keywords
- Obesity, Multimorbidity, Semaglutide, Glucagon-like peptide-1 receptor agonist, Physical activity, Exercise, Co-design, Patient-centred
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe obesity and multimorbidity | – | Combination Product: Semaglutide 2.4 mg, total diet replacement, behavioural interventionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 \> 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Unwillingness to participate in the study
- Inability to understand Danish
- Cognitive impairments
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 2.4 mg, total diet replacement, behavioural interventionAlso: Wegovy, Nupo, Dietary counselingPatients 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. | Combination product | Patients with severe obesity and multimorbidity |
Primary outcome
Habitual physical activity
Time frame: 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.
4 secondary outcomes
Health-related quality of life: physical
Time frame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
10-years cardiovascular risk (previous cardiovascular disease)
Time frame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
10-years cardiovascular risk (type 2 diabetes)
Time frame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
10-years cardiovascular risk (apparently healthy)
Time frame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasmus H Brødsgaard, MSc principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Morbid and Multimorbidity, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual physical activity (time frame: Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.