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Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)

28 mars 2022 uppdaterad av: Universitätsklinikum Hamburg-Eppendorf

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)

Prospective, international multicenter study to investigate the physical and psychological effects of the COVID-19 pandemic in two obese patient cohorts (BMI ≥ 25 kg/m²) pre- and post-bariatric surgery. In addition, the investigation of country-specific differences will be performed.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Pia Roser, MD
Telefonnummer: +494074100
E-post: p.roser@uke.de

Studieorter

Tyskland
- - Hamburg, Tyskland
    - Rekrytering
    - Universitätsklinikum Hamburg-Eppendorf
    - Kontakt:
      
      Pia Roser, MD
      
      Telefonnummer: 00494074100
      
      E-post: p.roser@uke.de

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Overweight and obese patients with or without bariatric surgery

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
PHQ-4 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Sekundära resultatmått

Resultatmått	Tidsram
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic Tidsram: 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 Tidsram: 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 Tidsram: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Samarbetspartners

King's College Hospital NHS Trust

Utredare

Huvudutredare: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2021

Primärt slutförande (Förväntat)

1 december 2022

Avslutad studie (Förväntat)

1 december 2022

Studieregistreringsdatum

Först inskickad

19 mars 2022

Först inskickad som uppfyllde QC-kriterierna

28 mars 2022

Första postat (Faktisk)

31 mars 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)