NCT01729650

Brief Summary

The aim is to evaluate the effectiveness of an intervention based on a program of physical activity and diet coordinated between primary care teams (PCT) and Mental Health Centres (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist circumference in patients with severe mental disorder diagnoses. To assess changes in cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized clinical trial with a control group, of one year of follow-up, carried out in four MHC Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18 - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with antipsychotic medication and a low level of PA. 240 patients will be selected in each group (difference to be detected in the BMI:\> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention: group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8 sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure, cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose. Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for repeated measures to adjust for differences attributable to the effect of the intervention for potential confounders: pharmacological treatment, care level of intervention and mental state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

November 14, 2012

Last Update Submit

August 31, 2016

Conditions

Schizophrenic DisordersSchizoaffective DisordersBipolar Disorders

Keywords

Psychotic Disorders,Heart Diseases

Outcome Measures

Primary Outcomes (3)

  • Change in weekly level of physical activity (IPAQ questionnaire),

    : the outcome measure is studied at 3, 6 and 12 months

  • Body mass index (kg/m²)

    : the outcome measure is studied at 3, 6 and 12 months

  • waist circumference (cm)

    : the outcome measure is studied at 3, 6 and 12 months

Secondary Outcomes (6)

  • blood pressure (mm hg)

    the outcome measure is studied at 3, 6 and 12 months

  • cardiovascular risk with the Regicor coronary risk to 10 years

    the outcome measure is studied at 3, 6 and 12 months

  • Quality of life (SF-36 questionnaire)

    the outcome measure is studied at 3, 6 and 12 months

  • Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.

    the outcome measure is studied at 3, 6 and 12 months

  • Dietary habits (PREDIMED questionnaire)

    the outcome measure is studied at 3, 6 and 12 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Clinical Global Impression, CGI

    the outcome measure is studied at 3, 6 and 12 months

  • BPRS (Brief Psychiatric Rating Scale)

    the outcome measure is studied at 3, 6 and 12 months

Study Arms (2)

Physical and diet educational group

EXPERIMENTAL

group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses.

Behavioral: Physical and diet educational group

Usual clinical care

NO INTERVENTION

Interventions

Physical and diet educational groupBEHAVIORAL

educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.

Physical and diet educational group

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 65 years old,
  • understand Catalan or Spanish
  • will be located for at least twelve months.
  • Psychiatric disorders with ICD-10 diagnosis codes: F20\*, F31\* and F25\*.
  • Taking an antipsychotic drug at, a least, three months
  • Low physical activity level

You may not qualify if:

  • Active addiction to psychoactive drugs, except tobacco.
  • Pregnancy
  • Diseases that doesn't allow physical activity
  • Psychotic acute exacerbation in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol i Gurina Foundation

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (1)

  • Masa-Font R, Fernandez-San-Martin MI, Martin Lopez LM, Alba Munoz AM, Oller Canet S, Martin Royo J, San Emeterio Echevarria L, Olona Tabuena N, Ibarra Jato M, Barroso Garcia A, Gonzalez Tejon S, Tajada Vitales C, Diaz Mujica B, Vinas Cabrera L, Sanchis Catalan R, Salvador Barbarroja T. The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial. Eur Psychiatry. 2015 Nov;30(8):1028-36. doi: 10.1016/j.eurpsy.2015.09.006. Epub 2015 Oct 30.

    PMID: 26521223DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderHeart Diseases

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

ES(1)