Semaglutide and Physical Activity for Obesity and Multimorbidity

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Multimorbidity; Obesity Morbid
• Intervention / Treatment: Combination product: Semaglutide 2.4 mg, total diet replacement, behavioural intervention

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 Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Hvidovre, Capital Region, Denmark, 2650
      • Copenhagen University Hospital, Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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 > 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Combination product: Semaglutide 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.; Other Names: Wegovy; Dietary counseling; Nupo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 21 months (± 2 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	The patients' body weight will be measured and presented as mean percentual change in weight between baseline, four months, and follow-up.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Waist circumference	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Health-related quality of life: mental	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Weight bias internalization	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Cardiorespiratory fitness	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Lower body strength	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).
Walking capacity and endurance	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.	Baseline (± 2 weeks), 4 months (± 2 weeks) and 24 months (± 2 weeks).

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Rasmus H Brødsgaard, MSc, Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Semaglutide; Physical activity; Health-related quality of life; Multimorbidity; Cardiometabolic health; Glucagon-like peptide-1 receptor agonist; Co-design; Patient-centred; Wegovy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Semaglutide
• Other Study ID Numbers: F-23061071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No