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Completed

NCT Number: NCT02807688

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

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.

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Key information

Conditions

Psychotic Disorders Bipolar Disorder Bipolar Disorders Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOC 4° Servizio Psichiatria - ULSS 20, San Bonifacio, Verona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Promotion Intervention

Behavioral

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Physical examination

    Time frame: baseline

    Physical examination by psychiatrist

  2. Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)

    Time frame: baseline

    Questionnaire assessing chronic diseases, administered by investigators

  3. Change in blood pressure

    Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6

  4. Change in pulses

    Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6

  5. Change in Body Mass Index

    Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6

  6. Change in waist circumference

    Time frame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6

  7. Change in glycemia

    Time frame: baseline and month 6

  8. Change in haemoglobin A1C

    Time frame: baseline and month 6

  9. Change in LDL cholesterol

    Time frame: baseline and month 6

  10. Change in HDL cholesterol

    Time frame: baseline and month 6

  11. Change in triglyceridemia

    Time frame: baseline and month 6

  12. Electrocardiogram

    Time frame: baseline

  13. Medication History Schedule

    Time frame: baseline

    Ad hoc form filled in by psychiatrist on present and previous psychopharmacological or non psychopharmacological medications taken by the participant

  14. 36 Item Short Form Health Survey

    Time frame: beginning and month 6

  15. Verona Service Satisfaction Scale - European Version

    Time frame: beginning and month 6

Sponsors and collaborators

Lead sponsor

Azienda ULSS di Verona e Provincia

Other

Collaborators

  • FONDAZIONE CARIVERONA
  • Universita di Verona

Registry information

Official study 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

Acronym: PHYSICO-DSM-VR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2016
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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