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)

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity; COVID-19 Pandemic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Pia Roser, MD; Phone Number: +494074100; Email: p.roser@uke.de

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Pia Roser, MD; Phone Number: 00494074100; Email: p.roser@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese patients with or without bariatric surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-4	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Country-specific differences of the physical and psychological impact of 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	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Differences in psychological impact between obese patients with and without COVID-19 infection	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Body Weight; COVID-19; Overweight
• Other Study ID Numbers: 2021-100673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No