NUTRITION AND BEHAVIORAL CORE FOR COTAIM

本研究旨在确定轻度高血压患者的最佳治疗方案， 通过评估患者的生理和行为成分， 从个人健康和公共福利的角度来看， 血压变化、副作用、相关风险因素的变化，以及 心理和行为变量的变化。 为了实现这一 目标，三个饮食组成部分（1 -无饮食变化; 2 -减肥; 3 - 减少钠，增加钾）和三种药物方案（1 - 安慰剂、2 -噻嗪类利尿剂和3 -β受体阻滞剂） 通过3x 3析因设计。 九百一十八（918）轻度至 中度未经治疗的高血压个体，年龄25 - 65岁，110-150 %的理想体重，无主要终末器官损伤， 舒张压（DBP）在90-100之间的患者将入组三个 临床中心（阿尔伯特·爱因斯坦医学院，布朗克斯，纽约; 亚拉巴马大学伯明翰医学院; 位于杰克逊的密西西比医疗中心）。 协调中心将在 德克萨斯大学公共健康学院。 将在基线时确定生化和心理变量， 在适当的时间间隔。 主要的结果变量将是血液 六个月后的压力变化。 进一步的目标是确定 心血管风险以及心理功能和生活方式。 在 六个月，没有达到舒张压目标的人 高血压患者将使用抗高血压药物进行逐步治疗。 所有患者将接受最短12个月和最长12个月的随访。 总共30个月。 药物饮食治疗的长期疗效 除了所述的主要评价外，还将对模式进行评估 以上 规划将占用前六个月和诱导未来18个月 个月 过渡和结束将在第四年完成， 第四年的剩余时间将用于分析和出版。

This study proposes to determine optimal management of mild hypertensive patients by evaluating physiological and behavioral components that are important from a personal health and public welfare viewpoint, including blood pressure change, side effects, change in associated risk factors, and change in psychological and behavioral variables. In order to achieve this goal, three dietary components (1 - no dietary change; 2 - weight loss; 3 - decreased sodium, increased potassium) and three drug regimens (1 - placebo, 2 - thiazide diuretic and 3 - beta blocker) will be evaluated through a 3 x 3 factorial design. Nine hundred and eighteen (918) mild to moderate untreated hypertensive individuals, age 25 to 65 years, 110-150 per cent ideal weight without major end-organ damage, and with sitting diastolic blood pressures (DBP) between 90-100 will be enrolled in three clinical centers (Albert Einstein College of Medicine, The Bronx, New York; University of Alabama at Birmingham Medical School; and the University of Mississippi Medical Center at Jackson). The Coordinating Center will be at the University of Texas School of Public Hedalth in Houston. Biochemical and psychological variables will be determined at baseline, and at appropriate intervals. The major outcome variable will be blood pressure change at six months. Further aims are to determine changes in cardiovascular risk and in psychological functioning and life style. At six months, individuals who have not reached their goal diastolic blood pressures will have a step-up therapy utilizing an antihypertensive drug. All patients will be followed for a minimum of twelve months and a maximum of thirty months in total. The long-term efficacy of drug diet treatment patterns will be assessed in addition to the primary evaluation described above. Planning will occupy the first six months and induction the next eighteen months. Transition and close-out will be completed during the fourth year, and the remainder of the fourth year will be analyses and publication.