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临床试验/NCT00398060
NCT00398060已完成3 期

GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care

Finnish Institute for Health and Welfare2 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2003年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
389
试验地点
2
主要终点
Nutrition (fat, fiber)

研究概览

简要总结

Life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.

详细描述

The GOAL (Good Ageing in Lahti region) Program Life-style change implementation trial to prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change counselling in the primary health care. In the intervention, specific nutritional, physical activity and weight loss objectives shown effective in diabetes prevention in an earlier randomised controlled trial are used as a benchmark, embedded in a structured group counselling model with an empowerment-oriented approach and adapted into the primary health care setting. In the trial, effectiveness and process are evaluated, the analyses including gender and socio-economic differences. Participants were 361 middle-aged (50-65 yrs) adults at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in Paijat-Hame, Finland. Intervention and data collection took place in year 2003.

研究设计

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

入排标准

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

入选标准

  • Type 2 diabetes risk test score > 11 (Lindstrom & Tuomilehto, 2003)

排除标准

  • mental health problem or substance abuse likely to interfere with participation
  • acute cancer
  • type 2 diabetes requiring pharmacological treatment
  • myocardial infarction during the past six months

结局指标

主要结局

Nutrition (fat, fiber)

时间窗: 0-1 years

Physical activity

时间窗: 0-3 years

Weight

时间窗: 0-3 years

次要结局

  • Waist circumference(0-3 years)
  • Plasma glucose (fasting, 2 hr challenge)(0-3 years)
  • Serum lipids(0-3 years)
  • Blood pressure (diastolic, systolic)(0-3 years)

研究者

发起方
Finnish Institute for Health and Welfare
申办方类型
Other Gov

研究点 (2)

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