Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
Study NCT ID:
NCT05303012
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PHQ-4', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic', 'description': '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.'}, {'measure': 'PSS-10', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic', 'description': '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.'}, {'measure': 'EDEQ-score', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic', 'description': '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.'}, {'measure': 'BMI', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Country-specific differences of the physical and psychological impact of the COVID-19 pandemic', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic'}, {'measure': 'Differences in psychological impact in obese patients pre- and post-bariatric surgery', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic'}, {'measure': 'Differences in psychological impact between obese patients with and without COVID-19 infection', 'timeFrame': 'Before the COVID-19 pandemic vs. since the COVID-19 pandemic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pandemic', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nObesity 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.\n\nTherefore, 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.\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight and obese patients with or without bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOverweight and obese patient cohort\n\n* Age: 18 years and older\n* BMI ≥ 25kg/m²\n\nOverweight and obese patient cohort with bariatric surgery\n\n* Age: 18 years and older\n* BMI ≥ 25kg/m²\n* Status post sleeve or gastric bypass surgery\n\nExclusion Criteria:\n\n* Age under 18 years\n* Cognitive, mental and/or linguistic limitations to complete the questionnaire independently\n* Severe somatic illnesses, such as tumour diseases\n* Pregnancy or breastfeeding\n* Acute need for treatment due to comorbid mental disorders'}, 'identificationModule': {'nctId': 'NCT05303012', 'briefTitle': 'Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '2021-100673'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overweight and obese patient cohort', 'description': '* Age: 18 years and older\n* BMI ≥ 25kg/m²'}, {'label': 'Overweight and obese patient cohort with bariatric surgery', 'description': '* Age: 18 years and older\n* BMI ≥ 25kg/m²\n* Status post sleeve or gastric bypass surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Pia Roser, MD', 'role': 'CONTACT', 'email': 'p.roser@uke.de', 'phone': '00494074100'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Pia Roser, MD', 'role': 'CONTACT', 'email': 'p.roser@uke.de', 'phone': '+494074100'}], 'overallOfficials': [{'name': 'Pia Roser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Hospital Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}