Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses

Psychotic Disorders Clinical Trial

— PHYSICO-DSM-VR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807688
• Other study ID #: CE 1518
• Status: Completed
• Phase: N/A
• First received: May 30, 2016
• Last updated: June 22, 2016
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2016
• Source: Azienda ULSS di Verona e Provincia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders
• Disease
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Health Promotion Intervention
The 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.

Locations

Country	Name	City	State
Italy	UOC 4° Servizio Psichiatria - ULSS 20	San Bonifacio	Verona
Italy	UOC 1° Servizio Psichiatria - ULSS 20	Verona
Italy	UOC 2° Servizio Psichiatria - ULSS 20	Verona
Italy	UOC 3° Servizio Psichiatria - ULSS 20	Verona

Sponsors (3)

Lead Sponsor	Collaborator
Azienda ULSS di Verona e Provincia	FONDAZIONE CARIVERONA, Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, month 1, month 2, month 3, month 4, month 5 and month 6	No
Secondary	Physical examination	Physical examination by psychiatrist	baseline	No
Secondary	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	baseline	No
Secondary	Change in blood pressure		baseline, month 1, month 2, month 3, month 4, month 5 and month 6	No
Secondary	Change in pulses		baseline, month 1, month 2, month 3, month 4, month 5 and month 6	No
Secondary	Change in Body Mass Index		baseline, month 1, month 2, month 3, month 4, month 5 and month 6	No
Secondary	Change in waist circumference		baseline, month 1, month 2, month 3, month 4, month 5 and month 6	No
Secondary	Change in glycemia		baseline and month 6	No
Secondary	Change in haemoglobin A1C		baseline and month 6	No
Secondary	Change in LDL cholesterol		baseline and month 6	No
Secondary	Change in HDL cholesterol		baseline and month 6	No
Secondary	Change in triglyceridemia		baseline and month 6	No
Secondary	Electrocardiogram		baseline	No
Secondary	Medication History Schedule	Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant	baseline	No
Secondary	36 Item Short Form Health Survey		beginning and month 6	No
Secondary	Verona Service Satisfaction Scale - European Version		beginning and month 6	No