Clinical trial NCT02807688: Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Bipolar Disorders
Keywords: health promotion
lifestyles
physical comorbidity
risk factors
behavioural change
Lead sponsor: Azienda ULSS di Verona e Provincia
Sponsor class: OTHER
Collaborators: name: FONDAZIONE CARIVERONA
name: Universita di Verona
First posted: 2016-06-21
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the number of participants that comply with WHO recommendations on diet and/or exercise
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Secondary outcomes:
measure: Physical examination
timeFrame: baseline
measure: Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)
timeFrame: baseline
measure: Change in blood pressure
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
measure: Change in pulses
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
measure: Change in Body Mass Index
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
measure: Change in waist circumference
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
measure: Change in glycemia
timeFrame: baseline and month 6
measure: Change in haemoglobin A1C
timeFrame: baseline and month 6
measure: Change in LDL cholesterol
timeFrame: baseline and month 6
measure: Change in HDL cholesterol
timeFrame: baseline and month 6
measure: Change in triglyceridemia
timeFrame: baseline and month 6
measure: Electrocardiogram
timeFrame: baseline
measure: Medication History Schedule
timeFrame: baseline
measure: 36 Item Short Form Health Survey
timeFrame: beginning and month 6
measure: Verona Service Satisfaction Scale - European Version
timeFrame: beginning and month 6
Other outcomes:
Locations:
city: San Bonifacio
country: Italy
facility: UOC 4° Servizio Psichiatria - ULSS 20
state: Verona
city: Verona
country: Italy
facility: UOC 1° Servizio Psichiatria - ULSS 20
city: Verona
country: Italy
facility: UOC 2° Servizio Psichiatria - ULSS 20
city: Verona
country: Italy
facility: UOC 3° Servizio Psichiatria - ULSS 20
Study officials:
affiliation: Universita di Verona
name: Lorenzo Burti, Professor
role: PRINCIPAL_INVESTIGATOR
References: