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

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University of Cincinnati

Status

Completed

Conditions

Hypertension
Pre-Hypertension

Treatments

Other: Routine Care
Behavioral: DASH-4-Teens

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00585832
R01HL088567 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

207 patients

Sex

All

Ages

11 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

207 participants in 2 patient groups

DASH-4-Teens Intervention
Experimental group
Description:
DASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Treatment:
Behavioral: DASH-4-Teens
Routine Care
Other group
Description:
Routine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Treatment:
Other: Routine Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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