Psychotic DisordersPHYSICO-DSM-VRNCT02807688
Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses
A study testing Health Promotion Intervention in people with Psychotic Disorders and Bipolar Disorders, run by Azienda ULSS di Verona e Provincia at 4 sites in Italy.
Trial summary
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Bipolar Disorders
- What is being tested?
- Health Promotion Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 4 sitesItaly
- Study dates
- Mar 2012to Mar 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3)
- one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment
- Age 18-65
Who cannot join
- moderate or severe mental handicap (learning disability)
- organic brain disorders
- lack of capacity to consent to inclusion
- subjects already involved in individual treatment related to diet and physical exercise
- subjects deemed unable or unfit to participate in the proposed physical activities
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
UOC 4° Servizio Psichiatria - ULSS 20
San Bonifacio, Verona, 37047
UOC 1° Servizio Psichiatria - ULSS 20
Verona, Verona, 37126
UOC 2° Servizio Psichiatria - ULSS 20
Verona, Verona, 37126
UOC 3° Servizio Psichiatria - ULSS 20
Verona, Verona, 37134
About this study
Official title: PHYSICO-DSM-VR - Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses: a Prevalence Study and a Randomised Controlled Study
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.
Read the detailed description
Epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. These findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects.
The number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. The present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.
- Conditions
- Psychotic Disorders, Bipolar Disorders
- Being tested
- Health Promotion Intervention
- Keywords
- health promotion, lifestyles, physical comorbidity, risk factors, behavioural change
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion InterventionBehavioural
The intervention package consists of the following elements:
- educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | "Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques. Receives: Behavioral: Health Promotion Intervention |
| Control | No intervention | Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of participants that comply with WHO recommendations on diet and/or exercise
Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Secondary outcomes (15)
Physical examination
Physical examination by psychiatrist
Measured: baseline
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)
Questionnaire assessing chronic diseases, administered by investigators
Measured: baseline
Change in blood pressure
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in pulses
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in Body Mass Index
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in waist circumference
Measured: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in glycemia
Measured: baseline and month 6
Change in haemoglobin A1C
Measured: baseline and month 6
Change in LDL cholesterol
Measured: baseline and month 6
Change in HDL cholesterol
Measured: baseline and month 6
Change in triglyceridemia
Measured: baseline and month 6
Electrocardiogram
Measured: baseline
Medication History Schedule
Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
Measured: baseline
36 Item Short Form Health Survey
Measured: beginning and month 6
Verona Service Satisfaction Scale - European Version
Measured: beginning and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda ULSS di Verona e Provincia
- Sponsor type
- University, hospital or other
- Collaborators
- FONDAZIONE CARIVERONA, Universita di Verona
- Responsible party
- Principal investigator, Lorenzo Burti, Universita di Verona
- Investigators
- Lorenzo Burti, Professor, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807688
- Sponsor's protocol ID
- CE 1518
- Acronym
- PHYSICO-DSM-VR
- Status last verified
- Jun 2016
- First submitted
- 30 May 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHYSICO-DSM-VR - Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses: a Prevalence Study and a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02807688
- Acronym / sponsor ID
- PHYSICO-DSM-VR / CE 1518
- Conditions
- Psychotic Disorders, Bipolar Disorders
- Keywords
- health promotion, lifestyles, physical comorbidity, risk factors, behavioural change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Azienda ULSS di Verona e ProvinciaUniversity, hospital or other
- Collaborators
- FONDAZIONE CARIVERONA, Universita di Verona
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Jun 2016 (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.
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.
Detailed description
Epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. These findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects.
The number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. The present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health Promotion Intervention"Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques. |
| Control | No intervention | –Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3)
- one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment
- Age 18-65
Key exclusion criteria (5 listed)
- moderate or severe mental handicap (learning disability)
- organic brain disorders
- lack of capacity to consent to inclusion
- subjects already involved in individual treatment related to diet and physical exercise
- subjects deemed unable or unfit to participate in the proposed physical activities
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 |
|---|---|---|
| Health Promotion InterventionThe intervention package consists of the following elements: i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer. | Behavioural | Intervention |
Primary outcome
Change in the number of participants that comply with WHO recommendations on diet and/or exercise
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.
15 secondary outcomes
Physical examination
Time frame: baseline
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)
Time frame: baseline
Change in blood pressure
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in pulses
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in Body Mass Index
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in waist circumference
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in glycemia
Time frame: baseline and month 6
Change in haemoglobin A1C
Time frame: baseline and month 6
Change in LDL cholesterol
Time frame: baseline and month 6
Change in HDL cholesterol
Time frame: baseline and month 6
Change in triglyceridemia
Time frame: baseline and month 6
Electrocardiogram
Time frame: baseline
Medication History Schedule
Time frame: baseline
36 Item Short Form Health Survey
Time frame: beginning and month 6
Verona Service Satisfaction Scale - European Version
Time frame: beginning and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Lorenzo Burti, Professor principal investigator
Universita di Verona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion Intervention in people with Psychotic Disorders and Bipolar Disorders, run by Azienda ULSS di Verona e Provincia at 4 sites in Italy.
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 5 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: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of participants that comply with WHO recommendations on diet and/or exercise (time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6). 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 23 Jun 2016.