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

NCT ID: NCT05303012

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-01

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.

Conditions

COVID-19 Pandemic; Overweight and Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Overweight and obese patient cohort

• Age: 18 years and older
• BMI ≥ 25kg/m²

No interventions assigned to this group

Overweight and obese patient cohort with bariatric surgery

• Age: 18 years and older
• BMI ≥ 25kg/m²
• Status post sleeve or gastric bypass surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pia Roser, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Hospital Hamburg-Eppendorf

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Pia Roser, MD

Role: CONTACT

p.roser@uke.de

+494074100

Facility Contacts

Pia Roser, MD

Role: primary

p.roser@uke.de

00494074100

Other Identifiers

2021-100673

Identifier Type: -

Identifier Source: org_study_id