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Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial

NCT ID: NCT02323802

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity /Overweight Acute Myocardial Infarction (STEMI/ NSTEMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

educational group intervention

Intervention Type BEHAVIORAL

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% .

Group Type ACTIVE_COMPARATOR

prescriptive diet

Intervention Type BEHAVIORAL

Interventions

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educational group intervention

Intervention Type BEHAVIORAL

prescriptive diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Chiara Muggia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation

Pavia, PV, Italy

Site Status RECRUITING

Cardiology department

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Chiara Muggia, MD

Role: primary

Arturo Raisaro, MD

Role: primary

Other Identifiers

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AMI-Obesity

Identifier Type: -

Identifier Source: org_study_id