Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
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
- 否
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
Sarah C. Couch
Professor
University of Cincinnati
