Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
Results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the Guidelines multidisciplinary measures aren't easily achievable.
Therefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. The study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic approach of prescriptive diet therapy.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Pavia, Italia, 27100
- Rekruttering
- Cardiology Department
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Ta kontakt med:
- Arturo Raisaro, MD
- Telefonnummer: +39 0382 502587
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PV
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Pavia, PV, Italia, 27100
- Rekruttering
- Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
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Ta kontakt med:
- Chiara Muggia, MD
- Telefonnummer: +39 0382 502190
- E-post: c.muggia@smatteo.pv.it
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Hovedetterforsker:
- Chiara Muggia, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Subjects of both sexes and age ≥ of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9.
Exclusion Criteria:
Patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: educational group intervention
The group educational food intervention: it provides the delivery of information leaflet and inclusion in groups on a weekly basis for the first 3 meetings, and then, there are other 2 meetings on the third and sixth month by the AMI. The meetings will cover education to self-nutrition, physical activity and learning techniques for stimulus control and management of high-risk situations. |
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Aktiv komparator: prescriptive diet
An objectives food scheme elaborated for each patients will provide the reduction in caloric intake (equivalent to 500-600 calories in deficit if compared to the estimated daily requirement, based on the RDAs) and a reduced intake of lipids, which does not exceed 30% of total calories introduced, with a contribution of saturated fat no more than 7-9% .
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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reduction of body weight
Tidsramme: 6 months
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The proportion of subjects with a 10% reduction in body weight at 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reduction of reinfarction and revascularization
Tidsramme: 1 year
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1 year
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general and specific mortality
Tidsramme: 1 year
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relative risk of death from all causes and from ischemic heart disease (no. of overall deaths and cardiovascular causes).
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1 year
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quality of life
Tidsramme: 6 months
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quality of life (assessed by SF-36 questionnaire at baseline and 6 months after infarction).
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AMI-Obesity
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