Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT04149756
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood 20ml, serum, plasma, peripheral blood mononuclear cell'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': 'after 6months', 'description': 'weight changes'}], 'secondaryOutcomes': [{'measure': 'lipid profile', 'timeFrame': 'after 6months', 'description': 'total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Reduction']}, 'descriptionModule': {'briefSummary': 'This study is intended to report changes in the weight and metabolic indicators of the subjects six months after the end of the study for adults with a risk factor of 27 kg/m2 or higher (formerly the research task name\\[clinicaltrial.gov;NCT03675191\\]).', 'detailedDescription': 'There was no special intervention after the previous research intervention. After the previous research was completed, we will check the changes in the body composition and metabolic indicators over six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Body mass index (BMI) more than 27kg/m2 with comorbidities or BMI more than 30kg/m2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who have participated in the previous trial (NCT03675191) and have completed the three-month study\n* Those who agreed the trial.\n\nExclusion Criteria:\n\n* Those who have withdrawn the previous trial (NCT03675191)'}, 'identificationModule': {'nctId': 'NCT04149756', 'briefTitle': 'Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'An Observation Study on Maintaining Weight for 6 Months After 3 Months of Weight Loss Program', 'orgStudyIdInfo': {'id': 'YI201905'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'overweight or obese adults', 'description': 'overweight or obese adults who participate the trial (NCT03675191)', 'interventionNames': ['Other: observation of weight after 6months']}], 'interventions': [{'name': 'observation of weight after 6months', 'type': 'OTHER', 'description': 'This study is an observational study for 96 people who have completed the previous weight loss program.\n\nWe will check the body composition and lipid profile of the participants who voluntarily visit after 6months after the end of the study. .', 'armGroupLabels': ['overweight or obese adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17046', 'city': 'Yongin', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yu-Jin Kwon, Dr', 'role': 'CONTACT'}], 'facility': 'Yongin Severance hospital'}], 'centralContacts': [{'name': 'Ji-Won Lee, PhD', 'role': 'CONTACT', 'email': 'indi5645@yuhs.ac', 'phone': '02-2019-3480'}, {'name': 'Yu-Jin Kwon, Dr', 'role': 'CONTACT', 'email': 'digda3@yuhs.ac', 'phone': '031-331-8710'}], 'overallOfficials': [{'name': 'Yu-Jin Kwon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji-Won Lee', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}