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Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

NCT ID: NCT03416439

Last Updated: 2018-01-31

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-02-28

Brief Summary

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The investigators compared the effectiveness of a lifestyle intervention program carried out by trained professionals versus standard unstructured information on healthy lifestyle given by the family physicians in ameliorating the metabolic pattern of adults with multiple metabolic and inflammatory abnormalities.

Detailed Description

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Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. It is unknown if a less intensive program might also be effective in the general population.

The investigators' aim was to compare the effectiveness of two different modalities that recommend a healthier lifestyle to reduce multiple metabolic abnormalities-a lifestyle intervention program with general recommendations carried out by trained professionals and standard unstructured information given by the family physician-in a dysmetabolic population-based cohort.

All subjects aged 45-64 (n=1,877) from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy), were contacted. A metabolic screening was carried out on 1,658 subjects (88.3%) who accepted to participate.

Out of those subjects, 375 patients had either the metabolic syndrome (MS) or two components of the MS plus high-sensitivity C-reactive protein (CRP) serum values ≥3 mg/L, the cutoff point that differentiates high-risk groups for future cardiovascular events, and did not have any of the exclusion criteria.

Then,187 were randomly allocated to the intervention arm and 188 to the control arm; 18 and 22 individuals refused to participate, respectively. Finally, 169 patients were assigned to the lifestyle intervention program carried out by trained professionals (intervention arm) and 166 to the standard, unstructured information given by the family physicians (control arm). All participants received verbal, not-written, information, emphasizing the importance of a healthy lifestyle from their family physicians, who had previously participated in 3 meetings on standard practice lifestyle recommendations. No further individualized programs were offered to the control arm.

The intervention arm received detailed verbal and written individualized diet and exercise recommendations from trained professionals during five 60-min sessions covering diet, exercise, and behavior modifications (the first was a one-to-one meeting, the following were group sessions).

Anthropometric measurements and blood samples were collected from all participants at the beginning and at the trial end, after 1-year.

Conditions

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Lifestyle Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention arm

lifestyle intervention program carried out by trained professionals

Group Type EXPERIMENTAL

lifestyle intervention

Intervention Type OTHER

lifestyle intervention program carried out by trained professionals

control arm

standard, unstructured information given by the family physicians

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lifestyle intervention

lifestyle intervention program carried out by trained professionals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 45-64 from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy)
* Presence of the metabolic syndrome (MS) or hs-CRP\>3mg/l and 2 components of the MS

Exclusion Criteria

* diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Simona Bo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AT2004

Identifier Type: -

Identifier Source: org_study_id