Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor) (CapiCor)
31 augusti 2016 uppdaterad av: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Effectiveness of a Physical Activity and Diet Program, Coordinated Between Primary Care and Mental Health, to Modify Cardiovascular Risk Factors in Patients With Schizophrenia or Bipolar Disorder (CapiCor)
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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
332
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Barcelona, Spanien, 08007
- Jordi Gol i Gurina Foundation
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active addiction to psychoactive drugs, except tobacco.
- Pregnancy
- Diseases that doesn't allow physical activity
- Psychotic acute exacerbation in the last month
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Physical and diet educational group
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.
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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.
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Inget ingripande: Usual clinical care
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in weekly level of physical activity (IPAQ questionnaire),
Tidsram: : the outcome measure is studied at 3, 6 and 12 months
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: the outcome measure is studied at 3, 6 and 12 months
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Body mass index (kg/m²)
Tidsram: : the outcome measure is studied at 3, 6 and 12 months
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: the outcome measure is studied at 3, 6 and 12 months
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|
waist circumference (cm)
Tidsram: : the outcome measure is studied at 3, 6 and 12 months
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: the outcome measure is studied at 3, 6 and 12 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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blood pressure (mm hg)
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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cardiovascular risk with the Regicor coronary risk to 10 years
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Quality of life (SF-36 questionnaire)
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Dietary habits (PREDIMED questionnaire)
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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Clinical Global Impression, CGI
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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BPRS (Brief Psychiatric Rating Scale)
Tidsram: the outcome measure is studied at 3, 6 and 12 months
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the outcome measure is studied at 3, 6 and 12 months
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Samarbetspartners och utredare
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Samarbetspartners
Utredare
- Huvudutredare: MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
14 november 2012
Först inskickad som uppfyllde QC-kriterierna
19 november 2012
Första postat (Uppskatta)
20 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PI11/01861
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