Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

NCT00585832 | Completed DMC

• 1 other identifier: R01HL088567
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Pre-Hypertension

Keywords

hypertension; pre-hypertension; adolescents; diet; vascular function

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (BP)

  BP measurements were performed with a mercury sphygmomanometer according to standardized procedures. BP was calculated from the average of 2 BP measurements. Systolic and diastolic BP z-scores were made based on established norms.

  change from baseline BP at immediately post-treatment (6 months)

Secondary Outcomes (2)

• Vascular Function

  change from baseline at immediately post-treatment (6 months)

• DASH dietary adherence

  change from baseline at immediately post-treatment (6 months)

Study Arms (2)

DASH-4-Teens Intervention

EXPERIMENTAL

DASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.

Behavioral: DASH-4-Teens

Routine Care

OTHER

Routine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.

Other: Routine Care

Interventions

DASH-4-Teens BEHAVIORAL

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

DASH-4-Teens Intervention

Routine Care OTHER

individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.

Routine Care

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed pre-hypertension or stage 1 hypertension
• years of age
• newly enrolled in the hypertension center at the Cincinnati Children's Hospital Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 33190559 RESULT

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah C Couch, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 3, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: through May 2023.
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

US (1)