Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial
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
- 否
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
lifestyle intervention program carried out by trained professionals
干预措施: lifestyle intervention (Other)
control arm
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
Simona Bo
Associate Professor
University of Turin, Italy
