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Completed

NCT Number: NCT03416439

Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

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.

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Key information

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle intervention

Other

lifestyle intervention program carried out by trained professionals

Primary outcomes

  1. Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria

    Time frame: 1 year after randomization

    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).

Secondary outcomes

  1. Within- and between-group variations in arterial blood pressure

    Time frame: 1 year after randomization

  2. Within- and between-group variations in weight values

    Time frame: 1 year after randomization

  3. Within- and between-group variations in fasting glucose

    Time frame: 1-year after randomization

  4. Within- and between-group variations in C-reactive protein values

    Time frame: 1-year after randomization

  5. Within- and between-group variations in triglyceride values

    Time frame: 1-year after randomization

  6. Within- and between-group variations in HDL-cholesterol values

    Time frame: 1-year after randomization

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Jan 31, 2018
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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