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临床试验/NCT00621569
NCT00621569已完成不适用

A Culturally Appropriate Intervention in Hypertensive African-Americans Based on the DASH Diet-The ADAPT Hypertension Study = Altering Diet for African American Populations to Treat Hypertension

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2005年1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
122
试验地点
2
主要终点
Change in blood pressure with dietary intervention

研究概览

简要总结

The purpose of the study is to develop a culturally appropriate DASH intervention and test the effectiveness of the intervention lower blood pressure in a group of African American participants at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).

详细描述

The effectiveness of the Dietary Approaches to Stop Hypertension (DASH) diet has shown to have limited impact on blood pressure control among African Americans, which might be explained by inappropriate adaptation to African American culture and tradition. Therefore, the adequate adaptation of the DASH diet would result in blood pressure control among African-Americans. Using the nominal group technique as a part of the formative assessment, this project proposes to identify key cultural variables that impact dietary patterns for African Americans. Based on those results, a modified behavioral intervention will be developed and tested in African Americans with pre-hypertension or stage I hypertension. Primary outcomes will include change in systolic and diastolic blood pressure at six months. It is expected that this project will contribute an additional tool for physicians, patients and health care systems to improve hypertension control amongst African Americans. The specific aims for this dietary intervention are: (1) to develop a modified DASH dietary pattern that is culturally appropriate for African-Americans by using principals of formative analysis and (2) to conduct a randomized, controlled trial to determine the effectiveness of the modified DASH dietary pattern in reducing blood pressure for a cohort of African-Americans with pre-hypertension or stage I hypertension to a usual care control group.

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
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Baseline SBP 120-159 mmHg and DBP 80-95 mmHg
  • Age 25 or older as of the initial screening visit
  • Willing and able to participate fully in all aspects of the intervention
  • Not on rigid diet
  • Provide informed consent
  • BMI 18.5-45 kg/m2

排除标准

  • Regular use of anti-hypertensive drugs or other drugs that raise or lower BP (any in previous three months)
  • Current use of insulin or oral hypoglycemic agents
  • Use of oral corticosteroids >5 days/month on average
  • Current use of medications for treatment of psychosis or manic-depressive illness
  • Use of oral breathing medications other than inhalers > 5 days/month on average
  • Use of weight-loss medications in previous 3 months

结局指标

主要结局

Change in blood pressure with dietary intervention

时间窗: 6 months

次要结局

  • Change in weight(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamy Ard, MD

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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