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)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Pia Roser, MD
- Telefonnummer: +494074100
- E-mail: p.roser@uke.de
Studiesteder
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-
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Hamburg, Tyskland
- Rekruttering
- Universitatsklinikum Hamburg-Eppendorf
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Kontakt:
- Pia Roser, MD
- Telefonnummer: 00494074100
- E-mail: p.roser@uke.de
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PHQ-4
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
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.
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
|
PSS-10
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
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.
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
|
EDEQ-score
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
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.
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
|
BMI
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
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.
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
|
Differences in psychological impact in obese patients pre- and post-bariatric surgery
Tidsramme: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
|
Differences in psychological impact between obese patients with and without COVID-19 infection
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-100673
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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