Personal SatisfactionURCULTHEANCT02426528
R.CULT.HEA - URban Environment, CULTural Social Use of Space and HEAlth / Well-being Effect on Population
A study testing Cultural and Social exposure in people with Personal Satisfaction and Health Behavior, run by University of Bologna.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction, Health Behavior
- What is being tested?
- Cultural and Social exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participants no having the previous features
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- Cultural and Social exposure
- Medical subject headings
- Personal Satisfaction, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural and Social exposureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cultural and Social exposure A | Experimental | Cultural and Social exposure Receives: Other: Cultural and Social exposure |
| Cultural and Social exposure B | No intervention | Non Intervention (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after 24 months (end of study)
Secondary outcomes (2)
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
Measured: 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
Measured: after 24 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Tavano Blessi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426528
- Sponsor's protocol ID
- UBologna
- Acronym
- URCULTHEA
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2015
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02426528
- Acronym / sponsor ID
- URCULTHEA / UBologna
- Conditions
- Personal Satisfaction, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cultural and Social exposure A | Experimental | Other: Cultural and Social exposureCultural and Social exposure |
| Cultural and Social exposure B | No intervention | –Non Intervention (Control Group) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- participants no having the previous features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultural and Social exposureThe 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). | Other | Cultural and Social exposure A |
Primary outcome
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
2 secondary outcomes
MHC-SF (Mental Health Continuum - Long Form MHC-LF)
Time frame: after 24 months (end of study)
SF-12 Health Survey
Time frame: after 24 months (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
Related trials for Personal Satisfaction
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cultural and Social exposure in people with Personal Satisfaction and Health Behavior, run by University of Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GIORGIO TAVANO BLESSI, PHD (+39.3894898278, G.TAVANO@IUAV.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGWBI (The Psychological General Well-Being Index) (time frame: after 24 months (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.