Obesity /OverweightNCT02323802
Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
A study testing educational group intervention and prescriptive diet in people with Obesity /Overweight and Acute Myocardial Infarction (STEMI/ NSTEMI), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity /Overweight, Acute Myocardial Infarction (STEMI/ NSTEMI)
- What is being tested?
- educational group intervention and prescriptive diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
Pavia, PV, 27100
Chiara Muggia, MD, +39 0382 502190, c.muggia@smatteo.pv.it
Chiara Muggia, MD
- Recruiting
Cardiology department
Pavia, 27100
Arturo Raisaro, MD, +39 0382 502587
About this study
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.
- Being tested
- educational group intervention, prescriptive diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational group interventionBehavioural
prescriptive dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| educational group intervention | Experimental | 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. Receives: Behavioral: educational group intervention |
| prescriptive diet | Active comparator | 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% . Receives: Behavioral: prescriptive diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of body weight
The proportion of subjects with a 10% reduction in body weight at 6 months
Measured: 6 months
Secondary outcomes (3)
Reduction of reinfarction and revascularization
Measured: 1 year
general and specific mortality
relative risk of death from all causes and from ischemic heart disease (no. of overall deaths and cardiovascular causes).
Measured: 1 year
quality of life
quality of life (assessed by SF-36 questionnaire at baseline and 6 months after infarction).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity /OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Muggia, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323802
- Sponsor's protocol ID
- AMI-Obesity
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02323802
- Acronym / sponsor ID
- AMI-Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| educational group intervention | Experimental | Behavioral: educational group interventionThe 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. |
| prescriptive diet | Active comparator | Behavioral: prescriptive dietAn 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% . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational group intervention | Behavioural | educational group intervention |
| prescriptive diet | Behavioural | prescriptive diet |
Primary outcome
reduction of body weight
Time frame: 6 months
The proportion of subjects with a 10% reduction in body weight at 6 months
3 secondary outcomes
Reduction of reinfarction and revascularization
Time frame: 1 year
general and specific mortality
Time frame: 1 year
quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
Pavia, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational group intervention and prescriptive diet in people with Obesity /Overweight and Acute Myocardial Infarction (STEMI/ NSTEMI), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of body weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.