Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

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.

Study Overview

• Status: Completed
• Conditions: Lifestyle Intervention
• Intervention / Treatment: Other: lifestyle intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; lifestyle intervention program carried out by trained professionals	Other: lifestyle intervention; lifestyle intervention program carried out by trained professionals
No Intervention: control arm; standard, unstructured information given by the family physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Within- and between-group variations in HDL-cholesterol values	1-year after randomization

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2004
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: AT2004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No