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

• Conditions: COVID-19 Pandemic; Overweight and Obesity

• Registration Number: NCT05303012
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSS-10	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.
BMI	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.
EDEQ-score	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.
PHQ-4	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.

Secondary Outcome Measures

Name	Time	Method
Differences in psychological impact between obese patients with and without COVID-19 infection	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany