Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.
Condition: Lifestyle Intervention
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): lifestyle intervention
Intervention type(s): Other
Intervention description(s): lifestyle intervention program carried out by trained professionals
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment