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临床试验/NCT00486941
NCT00486941已完成3 期

A Randomized Trial of Lifestyle Intervention in Primary Health Care for the Modification of Cardiovascular Risk Factors - the Björknäs Study

Umeå University2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2003年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
151
试验地点
2
主要终点
Changes in anthropometry (BMI, waist and hip cf)

研究概览

简要总结

The purpose of this study is to determine whether a short group intervention programe aiming at lifestyle changes at a local health centre can improve risk factors for cardiovascular disease

详细描述

Successfully transferring the findings of expensive and tightly controlled lifestyle intervention programmes to the primary care setting is necessary if such knowledge is to be used for disease prevention at the population level. Therefore, our objective was to evaluate the efficacy of a lifestyle intervention programe in the primary health care setting, targeted at patients with moderate- to high-risk of cardiovascular disease according to cardiovascular risk factor levels, physical activity and quality of life ratings.

Randomised controlled trial with follow-up at 3, 12, 24 and 36 months, carried out in a primary health care centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes or obesity were enrolled. The subjects were randomised to an intervention (n = 75) or control group (n = 76). 120 subjects completed the three-year follow-up. The intervention was based on the protocols used in the Finnish Diabetes Prevention study (DPS) and the U.S Diabetes Prevention Program

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients from one single health care centre with a diagnosis of:
  • Typ 2 diabetes,
  • Hypertension,
  • Obesity or
  • Dyslipidemia

排除标准

  • Coronary heart
  • BP >180/105,
  • Dementia; or
  • Severe psychiatric disease

结局指标

主要结局

Changes in anthropometry (BMI, waist and hip cf)

时间窗: 3 years

Maximal oxygen uptake (VO2max)

时间窗: 3 years

Health-related quality of life (EQ 5D, SF-36)

时间窗: 3 years

Self-reported physical activity

时间窗: 3 years

次要结局

  • Total cholesterol, HDL and triglycerides(3 years)
  • Glucose tolerance (OGTT)(3 years)
  • Blood pressure(3 years)

研究者

申办方类型
Other

研究点 (2)

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