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Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

U

University of Turin

Status and phase

Completed
Phase 3

Conditions

Lifestyle Intervention

Treatments

Other: lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

335 patients

Sex

All

Ages

45 to 64 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

335 participants in 2 patient groups

intervention arm
Experimental group
Description:
lifestyle intervention program carried out by trained professionals
Treatment:
Other: lifestyle intervention
control arm
No Intervention group
Description:
standard, unstructured information given by the family physicians

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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