Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT05949892
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart-health Promotion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Students in the control group will be masked from any form of the proposed intervention arms.'}, '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': '2023-07-01', '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': 'Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors', 'timeFrame': '6 months', 'description': 'Enhancing Heart-Health Preventive Behaviors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students'], 'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students', 'detailedDescription': 'The study intervention will be derived from the Expanded Health Belief Model which includes adhering to healthy diet, encouraging healthy weight, nutrition, and physical activity stress management, and smoking cessation and smoking avoidance.'}, '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 psychiatric-mental disorder\n\nExclusion Criteria:\n\n* High school female students who experience any psychiatric-mental disorder'}, 'identificationModule': {'nctId': 'NCT05949892', 'briefTitle': 'Heart-health Promotion', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Efficacy of The Expanded Health Belief Model-Based Intervention in Enhancing Heart-Health Preventive Behaviors Among High School Female Students: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Heart-Health Promotion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A healthy diet', 'description': 'This arm will focus on the following:\n\nEating lots of vegetables and fruit Choosing whole grain foods Eating protein foods Limiting highly and ultra-processed foods Highly processed foods Making water your drink of choice Salt, sodium and potassium Refraining from added sugars', 'interventionNames': ['Behavioral: Expanded Health Belief Model-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Weight Management', 'description': 'This arm will focus on the following:\n\nPhysical Activity for a Healthy Weight Preventing Weight Gain Choosing an Eating Plan to Prevent Weight Gain Balancing Food and Activity for Healthy Weight', 'interventionNames': ['Behavioral: Expanded Health Belief Model-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Physical Activity', 'description': 'This arm will focus on the following:\n\nStep 1: Make a commitment Step 2: Take stock of where you are Step 3: Set realistic goals Step 4: Identify resources for information and support Step 5: Continually "check in" with yourself to monitor your progress. Revisit the goals you set for yourself in Step 3 and evaluate your progress regularly', 'interventionNames': ['Behavioral: Expanded Health Belief Model-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Stress management', 'description': 'This arm will focus on the following:\n\nStress relief Relaxation techniques Meditation Mindfulness exercises', 'interventionNames': ['Behavioral: Expanded Health Belief Model-Based Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Smoking Cessation and Avoidance', 'description': 'This arm will focus on the following:\n\nSecond-hand smoke Offering option to avoid secondhand smoke', 'interventionNames': ['Behavioral: Expanded Health Belief Model-Based Intervention']}], 'interventions': [{'name': 'Expanded Health Belief Model-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'A healthy Diet Healthy Weight Physical Activity Stress Management Smoking Cessation and Avoidance', 'armGroupLabels': ['A healthy diet', 'Healthy Weight Management', 'Physical Activity', 'Smoking Cessation and Avoidance', 'Stress management']}]}, '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'}}}}