- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743257
How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)
The UrbASanté Study
Study Overview
Status
Conditions
Detailed Description
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).
UrbASanté 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).
Participants will be surveyed at enrollment and 24 months later.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Helene Charreire
- Phone Number: +330620604151
- Email: helene.charreire@u-pec.fr
Study Contact Backup
- Name: Benoit Conti
- Email: benoit.conti@univ-eiffel.fr
Study Locations
-
-
-
Créteil, France, 94000
- Recruiting
- Université Paris Est Créteil
-
Contact:
- Helene Charreire
- Phone Number: +330620604151
- Email: helene.charreire@u-pec.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Living in areas with urban intervention in Porte de la Chapelle, Paris (for experimental group)
- Living in areas without direct urban interventions close to Porte de la Chapelle, Paris (for control group)
- Age above 18 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental group
Volunteers living in a deprived neighborhood with urban transformations in Paris (France)
|
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.
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.
Sample of participants was interviewed about their food provisioning practice and living conditions.
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
|
Control group
Volunteers living in a deprived neighborhood without urban transformations in Paris (France).
|
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.
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.
Sample of participants was interviewed about their food provisioning practice and living conditions.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the mean adequacy ratio (MAR)
Time Frame: at baseline and 24 month later
|
Measure of individuals nutrient adequacy based on reported food intakes
|
at baseline and 24 month later
|
Change in the mean excess ratio (MER)
Time Frame: at baseline and 24 month later
|
Measure of excessive nutrient consumption, based on reported food intakes
|
at baseline and 24 month later
|
Change in physical activity behaviors
Time Frame: at baseline and 24 month later
|
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.
|
at baseline and 24 month later
|
Change in sedentary behaviors
Time Frame: at baseline and 24 month later
|
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.
|
at baseline and 24 month later
|
Change in perceived health
Time Frame: at baseline and 24 month later
|
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.
|
at baseline and 24 month later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age (in year) of each member of the household
Time Frame: at baseline
|
Participants were asked to report the age of each member of the household.
|
at baseline
|
Gender of adult members of the household
Time Frame: at baseline
|
Participants were asked to report the gender of each adult of the household
|
at baseline
|
Household income
Time Frame: at baseline
|
Participants indicated their net income bracket of the household (by month)
|
at baseline
|
Education level of each adult of the household
Time Frame: at baseline
|
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).
|
at baseline
|
Living duration (in month/year) in the residential neighborhood
Time Frame: at baseline
|
Participants were asked to indicate how long they had lived in the study area
|
at baseline
|
Marital status
Time Frame: at baseline
|
Participants were asked to report their marital status
|
at baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Helene Charreire, Université Paris Est Créteil
- Principal Investigator: Benoit Conti, Université Gustave Eiffel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- University Paris Est Creteil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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