NCT02807688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

May 30, 2016

Last Update Submit

June 22, 2016

Conditions

Psychotic DisordersBipolar Disorders

Keywords

health promotionlifestylesphysical comorbidityrisk factorsbehavioural change

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (15)

  • Physical examination

    baseline

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

    baseline

  • 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

  • +10 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

"Health Promotion Intervention" package including elements of psychoeducation on healthy lifestyles and practical sessions of physical activity, with the use of motivational techniques.

Behavioral: Health Promotion Intervention

Control

NO INTERVENTION

Control subjects receive treatment as usual at the Community Mental Health Services of the Department of Mental Health.

Interventions

Health Promotion InterventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • moderate or severe mental handicap (learning disability)
  • organic brain disorders
  • subjects already involved in individual treatment related to diet and physical exercise
  • subjects deemed unable or unfit to participate in the proposed physical activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UOC 4° Servizio Psichiatria - ULSS 20

San Bonifacio, Verona, 37047, Italy

Location

UOC 1° Servizio Psichiatria - ULSS 20

Verona, Verona, 37126, Italy

Location

UOC 2° Servizio Psichiatria - ULSS 20

Verona, Verona, 37126, Italy

Location

UOC 3° Servizio Psichiatria - ULSS 20

Verona, Verona, 37134, Italy

Location

MeSH Terms

Conditions

Psychotic DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Lorenzo Burti, Professor

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 21, 2016

Study Start

March 1, 2012

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

IT(4)