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

Health Behavior Clinical Trial

— URCULTHEA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02426528
• Other study ID #: UBologna
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: June 7, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2016
• Source: University of Bologna
• Contact: GIORGIO TAVANO BLESSI, PHD
• Phone: +39.3894898278
• Email: G.TAVANO[@]IUAV.IT
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 625
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Behavior
• Personal Satisfaction

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PGWBI (The Psychological General Well-Being Index)	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	after 24 months (end of study)	No
Secondary	MHC-SF (Mental Health Continuum - Long Form MHC-LF)	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	after 24 months (end of study)	No
Secondary	SF-12 Health Survey	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	after 24 months (end of study)	No