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Clinical Trials/NCT00585832
NCT00585832
Completed
Not Applicable

Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

University of Cincinnati1 site in 1 country207 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Cincinnati
Enrollment
207
Locations
1
Primary Endpoint
Blood Pressure (BP)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
October 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah C. Couch

Professor

University of Cincinnati

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Blood Pressure (BP)

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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