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临床试验/NCT00288327
NCT00288327已完成不适用

Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2003年3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
258
试验地点
2
主要终点
physical activity

研究概览

简要总结

The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.

详细描述

We conducted a 2 year study to test the feasibility and effectiveness of a CVD risk reduction intervention program for older, under or uninsured women. We used an existing nutrition and physical activity (PA) intervention tool (New Leaf...Choices for Healthy Living) designed specifically for this demographic group as part of the WISEWOMAN program (A CDC-funded CVD risk factor screening and intervention program for older, low-income women). We enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (LHAs); and 3) a community resource linkage component delivered primarily by LHAs. We tested the enhanced intervention in a randomized controlled trial in a community health center setting.

A total of 240 women aged 40-64 were randomized to the enhanced New Leaf intervention or minimum intervention groups. Women in the enhanced New Leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the CHC, postcard mailings, 3 group sessions, and lay health advisor (LHA) guided linkages to community resources for diet and PA. This was followed by a 6 month maintenance period led by the LHA and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. Primary outcome measures at 6 and 12 months included 1) PA measured by CSA accelerometer and 2) fruit, vegetable, and fat intake. Secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), CVD risk factors (total and HDL cholesterol, blood pressure), and psychosocial variables.

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
40 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 40-64 years old
  • Patient at participating site who is considered an appropriate candidate by the primary care clinician
  • Ability and willingness to provide informed consent
  • Availability for follow-up--plan to reside within 50 miles of study site for 1 year
  • Home phone or easy access to phone

排除标准

  • Medical condition for which intervention may not be appropriate
  • Pregnancy/lactation
  • Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate

结局指标

主要结局

physical activity

fruit intake

vegetable intake

fat intake

次要结局

  • Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
  • CVD risk factors (total and HDL cholesterol, blood pressure);
  • Psychosocial variables

研究者

申办方类型
Other

研究点 (2)

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