View Clinical Trial (Medical Research Study)
Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45229 |
| Conditions: |
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Hypertension - Prehypertension |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00585832 |
| Primary Contact: |
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Principal Investigator
Sarah C Couch, Ph.D.
University of Cincinnati
Sarah C Couch, Ph.D.
Phone: 513-558-7504
Email: Sarah.Couch@uc.edu
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| Backup Contact: |
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Email: Elaine.Urbina@cchmc.org
Elaine M Urbina, MD
Phone: 513-636-1350
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| Location Contact: |
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Cincinnati, Ohio 45229
United States
Amy Pflum, M.Ed., RD
Phone: 513-558-4048
Email: Amy.Pflum@uc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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