Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-06 @ 3:48 PM
Study NCT ID:
NCT03120260
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2017-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2017-04-15', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '12 Weeks', 'description': 'kg'}], 'secondaryOutcomes': [{'measure': 'Body mass index reduction', 'timeFrame': '12 Weeks', 'description': 'kg/m2'}, {'measure': 'Fasting plasma glucose level', 'timeFrame': '12 Weeks', 'description': 'mmol/l'}, {'measure': 'lipid profiles', 'timeFrame': '12 Weeks', 'description': 'mmol/l'}, {'measure': 'Insulin resistance (HOMA)', 'timeFrame': '12 Weeks', 'description': 'score'}, {'measure': 'liver enzymes (SGOT, SGPT)', 'timeFrame': '12 Weeks', 'description': 'U/l'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caloric Restriction', 'weight loss', 'sleep'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be female\n* Must have \\< 7 hour sleep per night\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\nExclusion Criteria:\n\n* Participating in a research project involving weight loss or physical activity in the previous six months.\n* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.\n* Taking medication 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': 'NCT03120260', 'briefTitle': 'Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program', 'organization': {'class': 'OTHER', 'fullName': 'Novindiet Clinic'}, 'officialTitle': 'Comparing the Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program: A 12 Week Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ND-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short Sleep', 'description': 'Diet+ have 5 hour sleep at night (SS)', 'interventionNames': ['Other: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Normal Sleep', 'description': 'Diet+ have 7-8 hour sleep at night (NS)', 'interventionNames': ['Other: Diet']}], 'interventions': [{'name': 'Diet', 'type': 'OTHER', 'description': "Intervention 'Diet+ short sleep versus normal sleep", 'armGroupLabels': ['Normal Sleep', 'Short Sleep']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'NovinDiet Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, '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'}}}}