Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05137405
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
THE IMPACT OF COVID-19 AMONG OBESE PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-26', 'size': 744587, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-27T13:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-27', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the impact of the Lock-down period on the mental and physical health of obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences during covid-19 pandemic.', 'timeFrame': 'March - May 2020', 'description': 'we have used a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Stay-at-home orders in response to the Coronavirus 2 (SARSCoV-2) have forced abrupt changes to daily routines.\n\nThe aim of our study is to evaluate the impact of the Stay-at-home orders on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic.\n\nMATERIALS AND METHODS: In this observational retrospective study, from the 9th of March to 18th May 2020, the patients of our Department were invited to answer to a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "An online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Alle obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic from March to May 2020\n\nExclusion Criteria:\n\n\\- Patients underwent bariatric surgery'}, 'identificationModule': {'nctId': 'NCT05137405', 'briefTitle': 'THE IMPACT OF COVID-19 AMONG OBESE PATIENTS', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'HOW THE IMPACT OF COVID-19 HOME STAY ORDERS IS AFFECTING THE PHYSICAL, MENTAL AND FINANCIAL HEALTH AMONG OBESE PATIENTS?', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'description': "An online survey format was administered to all obese patients on the waiting list for bariatric surgery in our Department of Medical and Surgical Sciences to obtain information about the COVID- 19 pandemic's impact on patients with obesity starting March 09, 2020 until May 18, 2020."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foggia', 'country': 'Italy', 'facility': 'Nicola Tartaglia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Giovanna Pavone', 'investigatorAffiliation': 'University of Foggia'}}}}