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Active, Not Recruiting

NCT Number: NCT06234111

Semaglutide and Physical Activity for Obesity and Multimorbidity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Morbid Behavior Body Weight Motor Activity Multimorbidity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Hvidovre

Hvidovre, Capital Region, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semaglutide 2.4 mg, total diet replacement, behavioural intervention

Combination Product

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, Nupo, Dietary counseling

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health-related quality of life: physical

    Time frame: 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.

  2. 10-years cardiovascular risk (previous cardiovascular disease)

    Time frame: 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.

  3. 10-years cardiovascular risk (type 2 diabetes)

    Time frame: 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.

  4. 10-years cardiovascular risk (apparently healthy)

    Time frame: 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 outcomes

  1. Body weight

    Time frame: 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.

  2. Waist circumference

    Time frame: 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.

  3. Health-related quality of life: mental

    Time frame: 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.

  4. Weight bias internalization

    Time frame: 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.

  5. Cardiorespiratory fitness

    Time frame: 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.

  6. Lower body strength

    Time frame: 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.

  7. Walking capacity and endurance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Semaglutide and Physical Activity for Obesity and Multimorbidity: Co-designing Healthy Healthcare

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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