Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

NCT03416439 | Completed Phase 3

• 1 other identifier: AT2004
• Study Type: interventional
• Target: 335
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year after randomization

Secondary Outcomes (6)

• Within- and between-group variations in arterial blood pressure

  1 year after randomization

• Within- and between-group variations in weight values

  1 year after randomization

• Within- and between-group variations in fasting glucose

  1-year after randomization

• Within- and between-group variations in C-reactive protein values

  1-year after randomization

• Within- and between-group variations in triglyceride values

  1-year after randomization

Study Arms (2)

intervention arm

EXPERIMENTAL

lifestyle intervention program carried out by trained professionals

Other: lifestyle intervention

control arm

NO INTERVENTION

standard, unstructured information given by the family physicians

Interventions

lifestyle intervention OTHER

lifestyle intervention program carried out by trained professionals

intervention arm

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 31, 2018
• Study Start: September 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: February 1, 2006
• Last Updated: January 31, 2018

Record last verified: 2018-01