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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02807688
Other study ID # CE 1518
Secondary ID
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


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
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