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

UR.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population: Study Protocol for a Cluster Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Health Behavior; Personal Satisfaction
• Intervention / Treatment: Other: Cultural and Social exposure

• Study Type: Interventional
• Enrollment (Anticipated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GIORGIO TAVANO BLESSI, PHD; Phone Number: +39.3894898278; Email: G.TAVANO@IUAV.IT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Estimate): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: UBologna