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临床试验/NCT03681002
NCT03681002已完成不适用

Implementation of a Structured Lifestyle Program in a Primary Care Setting. Changes in Lifestyle and Effects on Cardiovascular Risk in Patients With High Cardiovascular Risk.

Uppsala University0 个研究点目标入组 450 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
主要终点
Change in physical activity

研究概览

简要总结

The aim of the present study is to describe and evaluate the effect of a structured lifestyle intervention program, focusing on lifestyle habits, in a primary care setting in patients with high cardiovascular risk. Furthermore, we want to explore the patient´s experience of lifestyle change and counseling after participation in the intervention program and to investigate the cost-effectiveness of the program.

详细描述

Intervention The intervention program comprises five individual visits to the same nurse, specialised in diabetes care and the metabolic syndrome every three month during one year. The nurse led a person centered dialog based on the answers from a questionnaire. At every visit, focus was primarily on lifestyle habits, using motivational interviewing to strengthen the patient's ability to modify one or more lifestyle habits. Dietary counselling was in accordance with the Swedish recommendation in nutrition. If the patient were in need of extended counseling regarding one or more lifestyle habits, he or she could be referred within the primary care unit to a specialist. During the 12-month period, all patients where offered to participate in evening group sessions at three different occasions. Topics were physical activity, fatty acids, healthy food, tobacco and alcohol, stress, sleep and methods of how to change behavior".

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with
  • hypertension
  • diabetes mellitus type 2
  • impaired glucose tolerance

排除标准

  • severe psychiatric disease
  • difficulties to understand Swedish

研究组 & 干预措施

structured lifestyle program

Other

individual counseling focusing on Lifestyle habits

干预措施: structured lifestyle program (Behavioral)

结局指标

主要结局

Change in physical activity

时间窗: From baseline to 12 months

Patients rating perceived physical activity on a scale 0-10 at baseline and at 12 months

次要结局

  • Framingham risk score(From baseline to 12 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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