Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-08 @ 4:48 AM
Study NCT ID:
NCT05949918
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The researchers will use two groups (study and control) in which participants will be randomly selected and assigned in each of the study and control groups using simple random sampling.\n\nThe study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-07-09', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stages of Change Scale for Dietary Fat Reduction', 'timeFrame': '6 months', 'description': "Stages of Change Scale for Dietary Fat Reduction measures individuals' readiness to reduce dietary fat."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Fat Reduction']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.', 'detailedDescription': 'This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.\n\nThe study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.\n\nA 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'High school male students who do not experience any psychiatric-mental disorder.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High school male students who do not experience any psychiatric-mental disorder.\n\nExclusion Criteria:\n\n* High school male students who experience any psychiatric-mental disorder.'}, 'identificationModule': {'nctId': 'NCT05949918', 'briefTitle': 'Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction Among Female High School Students: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Dietary Fat Reduction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention', 'description': 'The intervention that would consider the Processes of Change that people use when they would be in the Precontemplation Stage of Change.', 'interventionNames': ['Behavioral: Stage-matched interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Contemplation-based intervention', 'description': 'The intervention that would consider the Processes of Change that people use when they would be in the Contemplation Stage of Change.', 'interventionNames': ['Behavioral: Stage-matched interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Preparation-based intervention', 'description': 'The intervention that would consider the Processes of Change that people use when they would be in the Preparation Stage of Change.', 'interventionNames': ['Behavioral: Stage-matched interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Action-based intervention', 'description': 'The intervention that would consider the Processes of Change that people use when they would be in the Action Stage of Change.', 'interventionNames': ['Behavioral: Stage-matched interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance-based intervention', 'description': 'The intervention that would consider the Processes of Change that people use when they would be in the Maintenance Stage of Change.', 'interventionNames': ['Behavioral: Stage-matched interventions']}], 'interventions': [{'name': 'Stage-matched interventions', 'type': 'BEHAVIORAL', 'description': 'The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.\n\nA 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.', 'armGroupLabels': ['Action-based intervention', 'Contemplation-based intervention', 'Maintenance-based intervention', 'Precontemplation, Contemplation, Preparation, Action, and Maintenance-based intervention', 'Preparation-based intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14149', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'University of Baghdad', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed Baqer Habeeb Abd Ali', 'investigatorAffiliation': 'University of Baghdad'}}}}