Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor) (CapiCor)
31. august 2016 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
332
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Barcelona, Spania, 08007
- Jordi Gol i Gurina Foundation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: Usual clinical care
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in weekly level of physical activity (IPAQ questionnaire),
Tidsramme: : 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)
Tidsramme: : 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
|
|
waist circumference (cm)
Tidsramme: : 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
blood pressure (mm hg)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
|
|
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Tidsramme: the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Clinical Global Impression, CGI
Tidsramme: 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)
Tidsramme: the outcome measure is studied at 3, 6 and 12 months
|
the outcome measure is studied at 3, 6 and 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
14. november 2012
Først innsendt som oppfylte QC-kriteriene
19. november 2012
Først lagt ut (Anslag)
20. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI11/01861
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