Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07043920
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Smoking on Physical Activity Level in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-21', 'studyFirstSubmitQcDate': '2025-06-21', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total physical activity score', 'timeFrame': 'At baseline (single timepoint)', 'description': 'Total weekly physical activity will be assessed using International Physical Activity Score- Short Form (IPAQ-SF) and expressed as MET-min/week. Categories will be created as inactive, minimally active, and very active.'}], 'secondaryOutcomes': [{'measure': 'Fagerström Test for Nicotine Dependence (FTND)', 'timeFrame': 'At baseline (single timepoint)', 'description': 'The Fagerström Test for Nicotine Dependence (FTND) is a widely used, standardized, 6-item questionnaire designed to assess the intensity of physical addiction to nicotine. The test evaluates behaviors and patterns related to cigarette smoking, including time to first cigarette after waking, number of cigarettes smoked per day, and difficulty refraining from smoking in forbidden areas. Each item is scored, and the total score ranges from 0 to 10.\n\nScore 0-3: Low dependence\n\nScore 4-6: Moderate dependence\n\nScore 7-10: High dependence\n\nThe FTND allows researchers and clinicians to categorize smokers according to their nicotine addiction level, which can be useful for tailoring interventions or for observational analysis of behavior and health outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Behaviors', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': 'This study will aim to examine the relationship between the daily physical activity level and nicotine dependence severity in university students. By identifying whether a higher physical activity level is associated with lower levels of smoking, the findings will help inform interventions to support healthier lifestyles in young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will consist of healthy university students aged 18 years and older, studying in health sciences departments in Istanbul, Türkiye. Both smokers and non-smokers will be included. Participants with cardiovascular disease, cancer, chronic pulmonary conditions, or pregnancy will be excluded.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years\n* Studying in a health-related university program\n* Healthy individuals (no known chronic disease)\n* Voluntarily agreeing to participate\n\nExclusion Criteria:\n\n* History of cardiovascular disease, cancer, or severe respiratory illness\n* Pregnancy\n* Age under 18'}, 'identificationModule': {'nctId': 'NCT07043920', 'briefTitle': 'Impact of Smoking on Physical Activity Level in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Association Between Daily Physical Activity Level and Nicotine Dependence in University Students: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'FA-Nosmoke-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoker Group', 'description': 'This group will consist of university students aged 18 years and older who report currently smoking cigarettes on a regular basis. Their level of nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). They will also complete the International Physical Activity Questionnaire-Short Form (IPAQ-SF) to evaluate their weekly physical activity levels.', 'interventionNames': ['Other: Behavioral Assessment (No therapeutic intervention will be administered)']}, {'label': 'Non-Smoker Group', 'description': 'This group will include university students aged 18 years and older who have never smoked or used tobacco products. Their physical activity levels will be assessed using the IPAQ-SF. FTND will not be applied as they have no smoking history.', 'interventionNames': ['Other: Behavioral Assessment (No therapeutic intervention will be administered)']}], 'interventions': [{'name': 'Behavioral Assessment (No therapeutic intervention will be administered)', 'type': 'OTHER', 'description': 'Participants will complete two validated questionnaires:\n\nThe Fagerström Test for Nicotine Dependence (FTND) - to assess levels of nicotine dependence.\n\nThe International Physical Activity Questionnaire - Short Form (IPAQ-SF) - to quantify weekly physical activity levels (walking, moderate, vigorous).', 'armGroupLabels': ['Non-Smoker Group', 'Smoker Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Pehlivan', 'role': 'CONTACT', 'email': 'esra.pehlivan@sbu.edu.tr', 'phone': '+90 216 777 8 777'}], 'facility': 'Esra Pehlivan', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Esra Pehlivan, Associate Professor', 'role': 'CONTACT', 'email': 'esra.pehlivan@sbu.edu.tr', 'phone': '+90 216 777 8 777'}, {'name': 'Yaren Ören', 'role': 'CONTACT', 'email': 'orenyaren4@gmail.com', 'phone': '0 216 777 8 777'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ESRA PEHLIVAN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}