Trial record 8 of 22 for:    Open Studies | "Prehypertension"

Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure (DASH-4-Teens)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00585832
First received: December 27, 2007
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Hypertension
Prehypertension
Behavioral: DASH-4-Teens
Other: Routine Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vascular Function [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: February 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
DASH-4-Teens Intervention
Behavioral: DASH-4-Teens
24-week behavioral nutrition intervention emphasizing a diet high in fruits, vegetables and low fat dairy foods and that is low in fat and sodium
B
Routine Care
Other: Routine Care
individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • have a psychological or medical condition that may preclude them from full participation.
  • do not have full medical clearance from a physician to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585832

Contacts
Contact: Sarah C Couch, Ph.D. 513-558-7504 Sarah.Couch@uc.edu
Contact: Elaine M Urbina, MD 513-636-1350 Elaine.Urbina@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Amy Pflum, M.Ed., RD    513-558-4048    Amy.Pflum@uc.edu   
Contact: Sarah C Couch, Ph.D., RD    (513) 558-7504    Sarah.Couch@uc.edu   
Sub-Investigator: Elaine M Urbina, MD         
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Sarah C Couch, Ph.D. University of Cincinnati
  More Information

No publications provided

Responsible Party: Sarah C. Couch, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585832     History of Changes
Other Study ID Numbers: 1R01HL088567-01A1, 1R01HL088567-01A1
Study First Received: December 27, 2007
Last Updated: March 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
hypertension
pre-hypertension
adolescents
diet
vascular function

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014