Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

R.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population (URCULTHEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426528
Recruitment Status : Unknown
Verified June 2016 by Giorgio Tavano Blessi, University of Bologna.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2015
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Giorgio Tavano Blessi, University of Bologna

Brief Summary:
This cluster randomized trial will test the affect of individual participation in culturally- and socially-related activities on health and well-being, in comparison also with the classic individual determinant, in relation to urban renovation schemes. Investigators will using a questionnaire based on several areas such as individual psychological well-being (PGWBI), individual happiness positioning (Keyes Scale) and health status perception (SF-12 Health Survey). Secondary outcomes will be related to social capital density (relationships and trust), culture (participation) and religion. The survey will be undertaken in a mid-size Italian metropolitan area, namely the Metropolitan City of Bologna.

Condition or disease Intervention/treatment Phase
Personal Satisfaction Health Behavior Other: Cultural and Social exposure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: UR.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population: Study Protocol for a Cluster Randomized Trial
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Cultural and Social exposure A
Cultural and Social exposure
Other: Cultural and Social exposure
The intervention protocol will consist of 24 months of guided exposure and participation in social and cultural activities undertaken in the "Casa del Popolo". The participant will be asked to register for a specific type of event (fine arts, performing arts, and social and volunteering activities), duration and date in order that this information can be supplied for further evaluation. Control group participants will be asked to carry on their lives normally and maintain regular cultural and social activity throughout the duration of the study. At twelve months from the beginning of the observation participants of both groups will be checked (intermediate phase).

No Intervention: Cultural and Social exposure B
Non Intervention (Control Group)



Primary Outcome Measures :
  1. PGWBI (The Psychological General Well-Being Index) [ Time Frame: after 24 months (end of study) ]
    This is a self-administrated test with 22 items that assesses the subjective perception of psychological well-being. It has been divided into 6 categories: anxiety, depression, self-control, positivity, well-being, and health and vitality


Secondary Outcome Measures :
  1. MHC-SF (Mental Health Continuum - Long Form MHC-LF) [ Time Frame: after 24 months (end of study) ]
    This is a self-administered form and represents the short version (14 items) of the Mental Health Continuum - Long Form MHC-LF (12), the original forty-item instrument. As for the long form, the short one has been designed to measure emotional, psychological and social well-being described by the two-continuum model of positive health (10). Within this framework, participants can be identified as flourishing, languishing or enjoying moderate mental health; in other words the aim is to assess positive or negative mental health as a function of emotional, psychological, and social well-being

  2. SF-12 Health Survey [ Time Frame: after 24 months (end of study) ]
    This is a self-administered test that assesses global health status but from the subjective point of view. It has been divided into two principal subscales: The Physical Component Summary (PCS) and the Mental Component Summary (MCS). In particular, it allows us to assess concepts involving health, physical functions, pain, general health, vitality, social functioning, emotional functioning and mental health



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gender: men and women;
  • Age range between 18 and 75 years old;
  • Residency: in an area of 2 square kilometers surrounding the Casa del Popolo

Exclusion Criteria:

  • participants no having the previous features

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426528


Contacts
Layout table for location contacts
Contact: GIORGIO TAVANO BLESSI, PHD +39.3894898278 G.TAVANO@IUAV.IT

Sponsors and Collaborators
University of Bologna

Layout table for additonal information
Responsible Party: Giorgio Tavano Blessi, Postdoctoral fellow, University of Bologna
ClinicalTrials.gov Identifier: NCT02426528    
Other Study ID Numbers: UBologna
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016