Clinical trial NCT03416439: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lifestyle Intervention
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 335
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria
timeFrame: 1 year after randomization
Secondary outcomes:
measure: Within- and between-group variations in arterial blood pressure
timeFrame: 1 year after randomization
measure: Within- and between-group variations in weight values
timeFrame: 1 year after randomization
measure: Within- and between-group variations in fasting glucose
timeFrame: 1-year after randomization
measure: Within- and between-group variations in C-reactive protein values
timeFrame: 1-year after randomization
measure: Within- and between-group variations in triglyceride values
timeFrame: 1-year after randomization
measure: Within- and between-group variations in HDL-cholesterol values
timeFrame: 1-year after randomization
Other outcomes:
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