- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05303012
Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)
International, Prospective Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic on Two Obese Patient Cohorts Pre- and Post-bariatric Surgery (COBESITY-Study)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
The COVID-19 pandemic, first reported in November 2019, has led to a global health systems emergency. The number of confirmed COVID-19-associated deaths, according to WHO, is higher in countries with high obesity prevalence. However, whether obesity is an independent risk factor of the severity of COVID-19 remains unclear.
Obesity represents one of the major health problems worldwide and the COVID-19 pandemic is expected to further increase obesity prevalence rates. Initial research indicates that the pandemic has also led to an increased incidence and/or worsening of depression and eating disorders. Additional weight gain due to the COVID-19 pandemic may be suspected to increase the prevalence of psychological comorbidities in patients before weight-reducing surgery compared to patients who have already undergone weight-reducing surgery.
Therefore, the main aim of this international study is to gain a better understanding of the mental and physical effects of the coronavirus pandemic on obese patients before and after a weight-reducing surgery and use this to develop approaches for solutions. This study also aims to investigate the country-specific differences (Germany vs England) as well as the differences in the mental effects experienced by overweight patients who have or have not been infected with COVID-19.
To achieve these aims, obese patients aged 18 years and older, before and after weight-reducing surgery, will be recruited from the bariatric surgery clinic at King's College Hospital, NHS Trust Foundation as well as from the Medical University Hospital Hamburg-Eppendorf, Germany. Participants will be asked to complete a questionnaire about their health, socio-economic status, and the effects of the COVID-19 pandemic on their physical and mental health. The questionnaire will take 15 minutes to complete and can be done at home or during the patient's appointment at the bariatric surgery clinic to minimise unnecessary travel.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Pia Roser, MD
- Puhelinnumero: +494074100
- Sähköposti: p.roser@uke.de
Opiskelupaikat
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Hamburg, Saksa
- Rekrytointi
- Universitätsklinikum Hamburg-Eppendorf
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Ottaa yhteyttä:
- Pia Roser, MD
- Puhelinnumero: 00494074100
- Sähköposti: p.roser@uke.de
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
Overweight and obese patient cohort
- Age: 18 years and older
- BMI ≥ 25kg/m²
Overweight and obese patient cohort with bariatric surgery
- Age: 18 years and older
- BMI ≥ 25kg/m²
- Status post sleeve or gastric bypass surgery
Exclusion Criteria:
- Age under 18 years
- Cognitive, mental and/or linguistic limitations to complete the questionnaire independently
- Severe somatic illnesses, such as tumour diseases
- Pregnancy or breastfeeding
- Acute need for treatment due to comorbid mental disorders
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Overweight and obese patient cohort
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Overweight and obese patient cohort with bariatric surgery
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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PHQ-4
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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PSS-10
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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EDEQ-score
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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BMI
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Differences in psychological impact in obese patients pre- and post-bariatric surgery
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Differences in psychological impact between obese patients with and without COVID-19 infection
Aikaikkuna: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2021-100673
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