跳至主要内容
临床试验/NCT00680849
NCT00680849已完成不适用

Enhancing Support for Women With Type 2 Diabetes: Follow-Up

Oregon Research Institute1 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2003年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
227
试验地点
1
主要终点
Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues

研究概览

简要总结

This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.

详细描述

Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood "natural history" of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All participants in the original study are eligible. The inclusion criteria for the original study were:
  • diagnosis of type 2 diabetes for at least 6 months
  • being post-menopausal
  • living independently (e.g., not in an institution or nursing home)
  • having a telephone
  • ability to read English
  • not being developmentally disabled, and
  • living within 30 miles of the Eugene-Springfield metropolitan area.

排除标准

  • Exclusion criteria for the original study included:
  • being older than 75 years of age
  • having life-threatening illnesses, or
  • planning to move from the local area within the time span of the study.

结局指标

主要结局

Food Frequency Questionnaire for Fruits, Vegetables and percent calories from fat (FFQ) by Kristal and colleagues

时间窗: annually, 36 months - 84 months

次要结局

  • Lipids, weight loss(annually, 36 months - 84 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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