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

Not Applicable

Completed

• Conditions: Psychotic Disorders; Bipolar Disorders
• Interventions: Behavioral: Health Promotion Intervention

• Registration Number: NCT02807688
• Lead Sponsor: Azienda ULSS di Verona e Provincia

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Study First Submitted: 2016-05-30
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in the number of participants that comply with WHO recommendations on diet and/or exercise	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.

Secondary Outcome Measures

Name	Time	Method
Change in glycemia	baseline and month 6
Physical examination	baseline	Physical examination by psychiatrist
Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)	baseline	Questionnaire assessing chronic diseases, administered by investigators
Change in blood pressure	baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in pulses	baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in Body Mass Index	baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in waist circumference	baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Change in haemoglobin A1C	baseline and month 6
Change in LDL cholesterol	baseline and month 6
Change in HDL cholesterol	baseline and month 6
Change in triglyceridemia	baseline and month 6
Electrocardiogram	baseline
36 Item Short Form Health Survey	beginning and month 6
Medication History Schedule	baseline	Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
Verona Service Satisfaction Scale - European Version	beginning and month 6

Trial Locations

Locations (4)

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, Italy