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)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Pia Roser, MD
- Telefonní číslo: +494074100
- E-mail: p.roser@uke.de
Studijní místa
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Hamburg, Německo
- Nábor
- Universitatsklinikum Hamburg-Eppendorf
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Kontakt:
- Pia Roser, MD
- Telefonní číslo: 00494074100
- E-mail: p.roser@uke.de
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PHQ-4
Časové okno: 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
|
|
PSS-10
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
Časové okno: 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
Časové okno: 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
Časové okno: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2021-100673
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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