Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT05938634
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial Using Stage-matched Intervention Based on the Transtheoretical Model of Change to Enhance Engaging in Regular Physical Exercise Among High School Female Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants in the control group will be masked from the proposed intervention.\n\nParticipants in the study group (in each Stage of Change) will be masked from the type of intervention they are supposed to receive.'}, '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': '2024-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engaging in regular physical exercise', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Exercise']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial that uses a Stage-matched intervention based on the Transtheoretical Model of Change to enhance engaging in regular physical exercise among high school female students.', 'detailedDescription': 'A randomized controlled trial that uses a Stage-matched intervention based on the Transtheoretical Model of Change to enhance engaging in regular physical exercise among high school female students.\n\nThe 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.\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 female students', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High school female students who do not experience any physical disability.\n\nExclusion Criteria:\n\n* High school female students who experience any physical disability.'}, 'identificationModule': {'nctId': 'NCT05938634', 'briefTitle': 'A Randomized Controlled Trial Using Stage-matched Intervention Based on the Transtheoretical Model of Change to Enhance Engaging in Regular Physical Exercise Among High School Female Students.', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': "Efficacy of Stage Matched Intervention Based on the Transtheoretical Model of Change in Enhancing Female High School Students' Readiness to Engage in Regular Physical Exercise: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'Regular Physical Exercise TTM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precontemplation', 'description': 'The intervention that would involve 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 involve 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 involve 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 involve 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 involve 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': 'Precontemplation-based intervention Contemplation-based intervention Preparation-based intervention Action-based intervention Maintenance-based intervention', 'armGroupLabels': ['Action-based intervention', 'Contemplation-based intervention', 'Maintenance-based intervention', 'Precontemplation', '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'}, 'collaborators': [{'name': 'Nisreen Hameed Jebur', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty member', 'investigatorFullName': 'Mohammed Baqer Habeeb Abd Ali', 'investigatorAffiliation': 'University of Baghdad'}}}}