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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585832
First Posted: January 3, 2008
Last Update Posted: July 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sarah C. Couch, University of Cincinnati
  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 Pre-Hypertension Behavioral: DASH-4-Teens Other: Routine Care

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

Further study details as provided by Sarah C. Couch, University of Cincinnati:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ]

Secondary Outcome Measures:
  • Vascular Function [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ]
  • Dietary intake [ Time Frame: immediately post-treatment (6 months) and at 1 year follow-up ]

Enrollment: 207
Study Start Date: February 2008
Study Completion Date: October 2014
Primary Completion Date: October 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585832


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Sarah C Couch, Ph.D. University of Cincinnati
  More Information

Responsible Party: Sarah C. Couch, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585832     History of Changes
Other Study ID Numbers: 1R01HL088567-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2007
First Posted: January 3, 2008
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sarah C. Couch, University of Cincinnati:
hypertension
pre-hypertension
adolescents
diet
vascular function

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases