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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
325
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.
UOC 4° Servizio Psichiatria - ULSS 20
San Bonifacio, Verona, Italy
UOC 1° Servizio Psichiatria - ULSS 20
Verona, Verona, Italy
UOC 2° Servizio Psichiatria - ULSS 20
Verona, Verona, Italy
UOC 3° Servizio Psichiatria - ULSS 20
Verona, Verona, Italy
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.
Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Physical examination
Physical examination by psychiatrist
Time frame: 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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant
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