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