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临床试验/NCT00585832
NCT00585832已完成不适用

Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2008年2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
207
试验地点
2
主要终点
Blood Pressure (BP)

研究概览

简要总结

The purpose of this study is to examine the long term effects of a 24-week clinically-based behavioral nutrition intervention emphasizing the DASH diet compared to routine nutrition care on changing diet quality, blood pressure, hypertension status, and vascular function in adolescents with elevated blood pressure.

详细描述

Hypertension in youth is no longer a rare disease and the number of affected children and adolescents is growing with the evolving pediatric epidemic in the US. Hypertension tracks from adolescence into adulthood and has been linked with preclinical indicators of adverse cardiovascular events in adults. Early prevention and intervention efforts are needed to address this increasing public and individual health problem. Preliminary studies from our research group demonstrate promising short-term effects of a behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy that is also low in fat and sodium (the DASH diet) on lowering blood pressure (BP) in adolescents. The purpose of this application is to extend these findings by examining the long term effects of an improved 24-week clinically based behavioral nutrition intervention emphasizing the DASH diet (the DASH-4-Teens intervention) compared to routine nutrition care intervention on changing diet quality, BP, hypertension status, and vascular function in adolescents with elevated blood pressure. Adolescents with diagnosed pre-hypertension and stage 1 hypertension will be randomly assigned to receive either the DASH-4-teens intervention or routine nutrition care. The DASH-4- Teens intervention will include individual in-person nutrition counseling sessions, behavioral counseling telephone calls, and mailings. Routine nutrition care will include individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program. Primary outcomes will be measured in both conditions at 6 months (post-treatment) and at 1 year follow-up. Adherence to treatment will be measured as diet-related goals met, counseling session attendance, and telephone call and food monitoring completion. Findings are expected to improve the treatment of hypertensive adolescents in the clinical setting and contribute to the enhancement of the cardiovascular health of this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed pre-hypertension or stage 1 hypertension
  • 11-18 years of age
  • newly enrolled in the hypertension center at the Cincinnati Children's Hospital Medical Center

排除标准

  • stage 2 hypertension
  • secondary hypertension
  • are being treated with anti-hypertensive medications
  • have received prior formalized diet therapy to managed their blood pressure
  • have target organ damage (as defined by a left ventricular mass index >51
  • diagnosed type 1 or 2 diabetes
  • use medications known to alter blood pressure
  • are unwilling to stop use of vitamins, minerals or antacids
  • do not speak English
  • have a diagnosed eating disorder
  • have a psychological or medical condition that may preclude them from full participation.
  • do not have full medical clearance from a physician to participate

结局指标

主要结局

Blood Pressure (BP)

时间窗: change from baseline BP at immediately post-treatment (6 months)

BP measurements were performed with a mercury sphygmomanometer according to standardized procedures. BP was calculated from the average of 2 BP measurements. Systolic and diastolic BP z-scores were made based on established norms.

次要结局

  • Vascular Function(change from baseline at immediately post-treatment (6 months))
  • DASH dietary adherence(change from baseline at immediately post-treatment (6 months))

研究者

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

Sarah C. Couch

Professor

University of Cincinnati

研究点 (2)

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