Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 2:30 AM
Study NCT ID:
NCT05743257
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D000388', 'term': 'Air'}, {'id': 'D009622', 'term': 'Noise'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004787', 'term': 'Environmental Pollution'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the mean adequacy ratio (MAR)', 'timeFrame': 'at baseline and 24 month later', 'description': 'Measure of individuals nutrient adequacy based on reported food intakes'}, {'measure': 'Change in the mean excess ratio (MER)', 'timeFrame': 'at baseline and 24 month later', 'description': 'Measure of excessive nutrient consumption, based on reported food intakes'}, {'measure': 'Change in physical activity behaviors', 'timeFrame': 'at baseline and 24 month later', 'description': 'Assessed by questions from the Sedentary, Transportation, and Activity Questionnaire (STAQ) with added questions about perception of active modes (walking and cycling). Using indicators of time spent in different transport modes (car or motorized vehicle, public transport, walking, cycling, other active transport) assessing the past-week frequency and duration of transport.'}, {'measure': 'Change in sedentary behaviors', 'timeFrame': 'at baseline and 24 month later', 'description': 'Assessed by questions from the Sedentary, Transportation, and Activity Questionnaire (STAQ) using indicator of past week sitting time spent during transport, leisure and work/study.'}, {'measure': 'Change in perceived health', 'timeFrame': 'at baseline and 24 month later', 'description': 'Assessed by the question "How is your health in general? Is it…" (very good/good/fair/bad/very bad) as a standard and cost-effective measure in health surveys.'}], 'secondaryOutcomes': [{'measure': 'Age (in year) of each member of the household', 'timeFrame': 'at baseline', 'description': 'Participants were asked to report the age of each member of the household.'}, {'measure': 'Gender of adult members of the household', 'timeFrame': 'at baseline', 'description': 'Participants were asked to report the gender of each adult of the household'}, {'measure': 'Household income', 'timeFrame': 'at baseline', 'description': 'Participants indicated their net income bracket of the household (by month)'}, {'measure': 'Education level of each adult of the household', 'timeFrame': 'at baseline', 'description': 'Participants were asked to report the highest education level achieved by each adult of the household (no degree, primary school, secondary school degree, bachelor degree, tertiary degree).'}, {'measure': 'Living duration (in month/year) in the residential neighborhood', 'timeFrame': 'at baseline', 'description': 'Participants were asked to indicate how long they had lived in the study area'}, {'measure': 'Marital status', 'timeFrame': 'at baseline', 'description': 'Participants were asked to report their marital status'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health-Related Behavior']}, 'referencesModule': {'references': [{'pmid': '36922807', 'type': 'DERIVED', 'citation': 'Charreire H, Conti B, Bauchard L, Cisse NA, Perignon M, Rollet P, Perrin C, Blanchard S, Roda C, Feuillet T, Madelin M, Dupuis V, Evrard AS, Hellequin AP, Coll I, Larrue C, Baudet-Michel S, Vernouillet G, Ntsame-Abegue F, Fabre I, Mejean C, Oppert JM; UrbASante Study Group. A natural experiment to assess how urban interventions in lower socioeconomic areas influence health behaviors: the UrbASante study. BMC Public Health. 2023 Mar 15;23(1):498. doi: 10.1186/s12889-023-15388-2.'}]}, 'descriptionModule': {'briefSummary': 'The UrbASanté study is a quasi-experimental research that aimed at assessing the impact of urban transformations (a natural experiment) in the health related behaviors, environmental exposure and perceived- health.', 'detailedDescription': 'The UrbASAnté study is an interdisciplinary project evaluating the relationships between urban transformations (urban regeneration programs) and health related behaviors, environmental exposure (air pollution, noise) and health (perceived) in a deprived neighborhood in Paris (France).\n\nUrbASanté consists of quasi-experimental research (before/after protocol design) and includes an "exposed" group of inhabitants living in a neighborhood with urban transformation (intervention) and an "unexposed group" comprising inhabitants from neighborhood not undergoing urban changes (control).\n\nParticipants will be surveyed at enrollment and 24 months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Porte de la Chapelle (Paris, France)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in areas with urban intervention in Porte de la Chapelle, Paris (for experimental group)\n* Living in areas without direct urban interventions close to Porte de la Chapelle, Paris (for control group)\n* Age above 18 years'}, 'identificationModule': {'nctId': 'NCT05743257', 'briefTitle': 'How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)', 'organization': {'class': 'OTHER', 'fullName': 'Paris 12 Val de Marne University'}, 'officialTitle': 'The UrbASanté Study', 'orgStudyIdInfo': {'id': 'University Paris Est Creteil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Volunteers living in a deprived neighborhood with urban transformations in Paris (France)', 'interventionNames': ['Behavioral: Questionnaire', 'Behavioral: Food diary supply', 'Behavioral: Interviews (semi-structured)', 'Behavioral: air and noise']}, {'label': 'Control group', 'description': 'Volunteers living in a deprived neighborhood without urban transformations in Paris (France).', 'interventionNames': ['Behavioral: Questionnaire', 'Behavioral: Food diary supply', 'Behavioral: Interviews (semi-structured)', 'Behavioral: air and noise']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Each participant completes a questionnaire (online or paper version) about socio-demographic characteristics, health outcomes (general health, respiratory health, and weight status), physical activity and sedentary behaviors, perception of neighborhood characteristics, air quality, and noise exposure.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Food diary supply', 'type': 'BEHAVIORAL', 'description': 'Sample of participant was issued with a food supply diary to record details of their household food supply and related trips over 1-mo period. Household food supply included food purchases, food gift/donation, and potential crops. For each food purchase, participants provided details of date, place of purchase and foods purchased (name, quantity and expense incurred). When till receipts were available in grocery stores or supermarkets, participants were asked to collect them in an envelope placed at the end of the food supply diary.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Interviews (semi-structured)', 'type': 'BEHAVIORAL', 'description': 'Sample of participants was interviewed about their food provisioning practice and living conditions.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'air and noise', 'type': 'BEHAVIORAL', 'description': 'Sample of participant were instructed to wear air and noise sensors to record their daily environmental exposure for 7 consecutive days, except for sleeping, bathing and performing activities in the water. Particulate matter concentrations, the temperature, and the relative humidity were measured - the nitrogen dioxide (NO2) and ozone (O3) concentrations were determined with data loggers that integrate reliable electrochemical gas sensors. Noise levels was measured using noise dosimeters. Sensors were accompanied by an activity logbook in which participants were required to daily record time when awake and sleeping, and, if any, time and duration of workout or device removal', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Helene Charreire', 'role': 'CONTACT', 'email': 'helene.charreire@u-pec.fr', 'phone': '+330620604151'}], 'facility': 'Université Paris Est Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Helene Charreire', 'role': 'CONTACT', 'email': 'helene.charreire@u-pec.fr', 'phone': '+330620604151'}, {'name': 'Benoit Conti', 'role': 'CONTACT', 'email': 'benoit.conti@univ-eiffel.fr'}], 'overallOfficials': [{'name': 'Helene Charreire', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paris 12 Val de Marne University'}, {'name': 'Benoit Conti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Gustave Eiffel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris 12 Val de Marne University', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, {'name': 'University Gustave Eiffel', 'class': 'OTHER'}, {'name': 'National Research Agency, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professeur', 'investigatorFullName': 'Hélène Charreire', 'investigatorAffiliation': 'Paris 12 Val de Marne University'}}}}