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临床试验/NCT03416439
NCT03416439已完成3 期

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

University of Turin, Italy0 个研究点目标入组 335 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
335
主要终点
Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

intervention arm

Experimental

lifestyle intervention program carried out by trained professionals

干预措施: lifestyle intervention (Other)

control arm

No Intervention

standard, unstructured information given by the family physicians

结局指标

主要结局

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

时间窗: 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).

次要结局

  • Within- and between-group variations in triglyceride 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 HDL-cholesterol values(1-year after randomization)
  • Within- and between-group variations in weight values(1 year after randomization)
  • Within- and between-group variations in arterial blood pressure(1 year after randomization)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simona Bo

Associate Professor

University of Turin, Italy

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