Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-10 @ 10:14 PM
Study NCT ID:
NCT01804504
Status:
UNKNOWN
Last Update Posted:
2013-03-06
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Education on the Metabolic Syndrome of Subjects Who Are Frequently Eating Out
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.'}], 'secondaryOutcomes': [{'measure': 'Change in Blood pressure', 'timeFrame': 'Baseline and 24 weeks'}, {'measure': 'Change in waist circumference, waist hip ratio, waist to height', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Waist, hip circumference and height was measured using a plastic tape to the nearest 0.1 cm'}, {'measure': 'Change in Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm Change in fasting blood glucose', 'timeFrame': 'Baseline and 24 weeks'}, {'measure': 'Change in serum triglyceride, cholesterol, HDL, LDL', 'timeFrame': 'Baseline and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Eating out of home', 'Nutrition education'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The project is aimed at investigating the effect of nutrition education on knowledge, attitude and practice (KAP)of subjects who are frequently eating out, and the effect on metabolic parameters.', 'detailedDescription': 'The project is aimed at investigating the dietary structure and frequencies of eating out via a cross-sectional study, on the basis of which a randomized, parallel controlled trials is to be carried out.The purpose is to evaluate the effect on metabolic parameters.\n\nHypotheses to be tested:Nutrition education has the effect of improving the metabolic parameters of subjects who are frequently eating out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shanghai urban citizens\n* Male or female 18 to 25 years of age;\n* Frequently eat out(eat out 3 or more times per week);\n* Clinical diagnosis of Metabolic Syndrome(Meet 3 or more Diagnostic criteria); A. Abdominal obesity: waist circumference\\>90cm ( M ), and\\>85cm( F ); B. Dyslipidemia:triglyceride≥1.7mmol/L; C. HDL-C \\< 1.04mmol/L; D. hypertension: blood pressure≥ 130/85mm Hg ( or have been diagnosed hypertension); E. Hyperglycemia : FPG≥6.1mmol/L and ( or ) 2-hour postprandial blood glucose≥7.8mmol/L and ( or ) have been diagnosed with diabetes;\n* Signed written informed consent ;\n* Can attend lectures.\n\nExclusion Criteria:\n\n* Pregnant woman;\n* Temporary resident population;\n* Participating in another clinical trial 6 months before randomization.'}, 'identificationModule': {'nctId': 'NCT01804504', 'briefTitle': 'Nutrition Education on the Metabolic Syndrome of Subjects Who Are Frequently Eating Out', 'organization': {'class': 'OTHER', 'fullName': 'Second Military Medical University'}, 'officialTitle': 'Survey on Eating Out Behavior and Dietary Structure in Urban Chinese Citizens and the Effect of Nutrition Education', 'orgStudyIdInfo': {'id': '5186272761903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Food Frequency Questionnaire(FFQ) and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores.\n\nPhysical examination and biochemical examination before and after the trial.'}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition education', 'description': 'FFQ and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores.\n\nPhysical examination and biochemical examination before and after the trial.\n\nDo nutrition education', 'interventionNames': ['Behavioral: Nutrition education']}], 'interventions': [{'name': 'Nutrition education', 'type': 'BEHAVIORAL', 'description': 'The intervention group will be sent out a series of education materials, be arranged to attend lectures(once a month), dietary guidance or nutrition consultation at regular intervals(once every 2 weeks).', 'armGroupLabels': ['Nutrition education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital,Second Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Donglian Cai, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changhai Hospital ,Second Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Donglian Cai', 'investigatorAffiliation': 'Second Military Medical University'}}}}