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

NCT02426528 | Unknown

• 1 other identifier: UBologna
• Study Type: interventional
• Target: 625
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Personal Satisfaction; Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• MHC-SF (Mental Health Continuum - Long Form MHC-LF)

  after 24 months (end of study)

• SF-12 Health Survey

  after 24 months (end of study)

Study Arms (2)

Cultural and Social exposure A

EXPERIMENTAL

Cultural and Social exposure

Other: Cultural and Social exposure

Cultural and Social exposure B

NO INTERVENTION

Non Intervention (Control Group)

Interventions

Cultural and Social exposure OTHER

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).

Cultural and Social exposure A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• participants no having the previous features

Sponsors & Collaborators

• University of Bologna: lead

MeSH Terms

Conditions

Personal Satisfaction; Health Behavior

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Central Study Contacts

GIORGIO TAVANO BLESSI, PHD

CONTACT

+39.3894898278; G.TAVANO@IUAV.IT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 27, 2015
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: June 8, 2016

Record last verified: 2016-06