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Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

Primary Purpose

Lifestyle Intervention

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
lifestyle intervention
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lifestyle Intervention

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention arm

    control arm

    Arm Description

    lifestyle intervention program carried out by trained professionals

    standard, unstructured information given by the family physicians

    Outcomes

    Primary Outcome Measures

    Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria
    Metabolic syndrome was defined by the National Cholesterol Education Program criteria as the presence of ≥3 of the following five criteria: fasting glucose ≥6.1 mmol/L; blood pressure ≥ 130/85 mmHg; triglycerides ≥1.69 mmol/L; high-density lipoprotein (HDL) cholesterol <1.29 mmol/L (females) or <1.04 mmol/L (males), and waist circumference >88 cm (females) or >102 cm (males).

    Secondary Outcome Measures

    Within- and between-group variations in arterial blood pressure
    Within- and between-group variations in weight values
    Within- and between-group variations in fasting glucose
    Within- and between-group variations in C-reactive protein values
    Within- and between-group variations in triglyceride values
    Within- and between-group variations in HDL-cholesterol values

    Full Information

    First Posted
    January 22, 2018
    Last Updated
    January 29, 2018
    Sponsor
    University of Turin, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03416439
    Brief Title
    Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.
    Official Title
    Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (Actual)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Turin, Italy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lifestyle Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    335 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention arm
    Arm Type
    Experimental
    Arm Description
    lifestyle intervention program carried out by trained professionals
    Arm Title
    control arm
    Arm Type
    No Intervention
    Arm Description
    standard, unstructured information given by the family physicians
    Intervention Type
    Other
    Intervention Name(s)
    lifestyle intervention
    Intervention Description
    lifestyle intervention program carried out by trained professionals
    Primary Outcome Measure Information:
    Title
    Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria
    Description
    Metabolic syndrome was defined by the National Cholesterol Education Program criteria as the presence of ≥3 of the following five criteria: fasting glucose ≥6.1 mmol/L; blood pressure ≥ 130/85 mmHg; triglycerides ≥1.69 mmol/L; high-density lipoprotein (HDL) cholesterol <1.29 mmol/L (females) or <1.04 mmol/L (males), and waist circumference >88 cm (females) or >102 cm (males).
    Time Frame
    1 year after randomization
    Secondary Outcome Measure Information:
    Title
    Within- and between-group variations in arterial blood pressure
    Time Frame
    1 year after randomization
    Title
    Within- and between-group variations in weight values
    Time Frame
    1 year after randomization
    Title
    Within- and between-group variations in fasting glucose
    Time Frame
    1-year after randomization
    Title
    Within- and between-group variations in C-reactive protein values
    Time Frame
    1-year after randomization
    Title
    Within- and between-group variations in triglyceride values
    Time Frame
    1-year after randomization
    Title
    Within- and between-group variations in HDL-cholesterol values
    Time Frame
    1-year after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

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