Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT03828812
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep quality score', 'timeFrame': '1 year', 'description': 'Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality'}, {'measure': 'Mood status', 'timeFrame': '1 year', 'description': 'Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods'}], 'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': '1 year', 'description': 'Body weight in kilogram'}, {'measure': 'Standing height', 'timeFrame': '1 year', 'description': 'Height in meters'}, {'measure': 'Body fat%', 'timeFrame': '1 year', 'description': 'Bioimpedance method (TANITA BC-418)'}, {'measure': 'Body mass index', 'timeFrame': '1 year', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Systolic blood pressure', 'timeFrame': '1 year', 'description': 'Measured in mmHg (Microlife BP 3MS1-4K)'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '1 year', 'description': 'Measured in mmHg (Microlife BP 3MS1-4K)'}], 'secondaryOutcomes': [{'measure': 'Frequency of breakfast per week', 'timeFrame': '1 year', 'description': 'Self-report food frequency questionnaire(0-7 days/week)'}, {'measure': 'Frequency of nighttime snacking per week', 'timeFrame': '1 year', 'description': 'Self-report food frequency questionnaire(0-7 days/week)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Composition', 'Blood Pressure', 'Mealtimes']}, 'referencesModule': {'references': [{'pmid': '38860554', 'type': 'DERIVED', 'citation': 'Chen HJ, Tsai YC, Hsu YT, Chu J. Effect of recommendations of breakfast and late-evening snack habits on body composition and blood pressure: A pilot randomized trial. Chronobiol Int. 2024 Jul;41(7):1021-1033. doi: 10.1080/07420528.2024.2363492. Epub 2024 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year changes in blood pressure and body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult\n* Willing to participate\n\nExclusion criteria:\n\n* Being pregnant\n* hemodialysis patients\n* clinical diagnosis of cardiovascular diseases\n* clinical diagnosis of cancer\n* clinical diagnosis of dementia\n* clinical diagnosis of eating disorders\n* having metal orthopedic implants\n* having pacemaker implanted'}, 'identificationModule': {'nctId': 'NCT03828812', 'briefTitle': 'Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure', 'orgStudyIdInfo': {'id': 'YM104136E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Breakfast promotion', 'description': 'Receiving the recommendation of daily breakfast', 'interventionNames': ['Behavioral: Breakfast promotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nighttime snack reduction', 'description': 'Receiving the recommendation of reducing nighttime snack frequency', 'interventionNames': ['Behavioral: Nighttime snack reduction']}, {'type': 'EXPERIMENTAL', 'label': 'Breakfast promotion + nighttime snack reduction', 'description': 'Receiving the recommendation of daily breakfast + reducing nighttime snack frequency', 'interventionNames': ['Behavioral: Breakfast promotion', 'Behavioral: Nighttime snack reduction']}], 'interventions': [{'name': 'Breakfast promotion', 'type': 'BEHAVIORAL', 'description': 'Recommendation of having breakfast daily', 'armGroupLabels': ['Breakfast promotion', 'Breakfast promotion + nighttime snack reduction']}, {'name': 'Nighttime snack reduction', 'type': 'BEHAVIORAL', 'description': 'Recommendation of reducing frequency of nighttime snacking', 'armGroupLabels': ['Breakfast promotion + nighttime snack reduction', 'Nighttime snack reduction']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hsin-Jen Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Yang Ming Chiao Tung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hsin-Jen Chen', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}