Clinical trial NCT00585832: Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
Official title: Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Pre-Hypertension
Keywords: hypertension
pre-hypertension
adolescents
diet
vascular function
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-01-03
Enrollment: 207
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* have a psychological or medical condition that may preclude them from full participation.
* do not have full medical clearance from a physician to participate

Primary outcomes:
measure: Blood Pressure (BP)
timeFrame: change from baseline BP at immediately post-treatment (6 months)
Secondary outcomes:
measure: Vascular Function
timeFrame: change from baseline at immediately post-treatment (6 months)
measure: DASH dietary adherence
timeFrame: change from baseline at immediately post-treatment (6 months)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Sarah C Couch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Couch SC, Saelens BE, Khoury PR, Dart KB, Hinn K, Mitsnefes MM, Daniels SR, Urbina EM. Dietary Approaches to Stop Hypertension Dietary Intervention Improves Blood Pressure and Vascular Health in Youth With Elevated Blood Pressure. Hypertension. 2021 Jan;77(1):241-251. doi: 10.1161/HYPERTENSIONAHA.120.16156. Epub 2020 Nov 16.