Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-02-21 @ 6:55 PM
Study NCT ID:
NCT03171961
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2017-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2017-05-27', 'studyFirstSubmitQcDate': '2017-05-27', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': '24 Weeks', 'description': 'kg'}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '24 Weeks', 'description': 'cm'}, {'measure': 'Fasting blood glucose', 'timeFrame': '24 Weeks', 'description': 'mmol/l'}, {'measure': 'Fasting insulin level', 'timeFrame': '24 Weeks', 'description': 'mU/l'}, {'measure': 'HbA1c', 'timeFrame': '24 Weeks', 'description': 'score'}, {'measure': 'HOMA-IR', 'timeFrame': '24 Weeks', 'description': 'Percentage (%)'}, {'measure': 'lipid profiles', 'timeFrame': '24 Weeks', 'description': 'mmol/l'}, {'measure': 'liver function tests', 'timeFrame': '24 Weeks', 'description': 'U/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight loss', 'Diet', 'online visit', 'clinic visit'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'Online visit and online counseling via telemedicine technology is a new service for obese people who wish to lose weight but because of their active lifestyle and time limitation cannot come to clinic. The purpose of this study was to examine the efficacy this technology-based intervention on weight loss in obese and overweight female adults.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be female\n* Must be 18-45 years of age.\n* Must have Body mass index (BMI) between 27-35 kg/ m².\n* Must be able to have moderate exercise.\n* Must be interested to have weight loss.\n* Have access to the internet via broad- band ADSL or Mobile 4G\n\nExclusion Criteria:\n\n* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.\n* Taking medications that could affect metabolism or change body weight.\n* Report heart problems, chest pain, and cancer within the last five years.\n* Smoking\n* Menopause\n* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.'}, 'identificationModule': {'nctId': 'NCT03171961', 'briefTitle': 'Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Novindiet Clinic'}, 'officialTitle': 'Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss in Overweight and Obese Women, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ND-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'online visit group', 'description': 'in online visit group , subjects has online visit with dietitian every 2 weeks', 'interventionNames': ['Behavioral: online visit group']}, {'type': 'EXPERIMENTAL', 'label': 'clinic visit group', 'description': 'clinic visit group ,subject has every 2 weeks in person visit at clinic', 'interventionNames': ['Behavioral: Clinic visit group']}, {'type': 'EXPERIMENTAL', 'label': 'self-directed group', 'description': 'self-directed group ,subjects receive nutritional information via web and their energy needs for weight loss', 'interventionNames': ['Behavioral: self-directed group']}], 'interventions': [{'name': 'online visit group', 'type': 'BEHAVIORAL', 'otherNames': ['OV'], 'description': 'subjects has online visit with dietitian every 2 weeks+diet', 'armGroupLabels': ['online visit group']}, {'name': 'Clinic visit group', 'type': 'BEHAVIORAL', 'otherNames': ['CV'], 'description': 'Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet', 'armGroupLabels': ['clinic visit group']}, {'name': 'self-directed group', 'type': 'BEHAVIORAL', 'otherNames': ['SD'], 'description': 'self-directed group receives nutritional information via web and their energy needs for weight loss', 'armGroupLabels': ['self-directed group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'NovinDiet Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehrān', 'country': 'Iran', 'facility': 'NovinDiet Clinic', 'geoPoint': {'lat': 27.45845, 'lon': 55.47624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novindiet Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}