Lifestyle Intervention Clinical Trial
Official title:
Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial
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.
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.
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