Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

Hypertension Clinical Trial

— DASH-4-Teens  

Official title:

Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585832
• Other study ID #: R01HL088567
• Secondary ID: R01HL088567
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: October 2014

Study information

• Verified date: June 2022
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Hypertension
• Prehypertension

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

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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;7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vascular Function	Flow mediated dilation (FMD) of the brachial artery was assessed using B-mode ultrasound vascular imaging according to Corretti MS et al., (J Am Coll Cardiology 2002; 39: 257-265).	change from baseline at immediately post-treatment (6 months)
Secondary	DASH dietary adherence	Dietary intake was assessed using 3 random 24 hour recalls (2 weekdays, 1 weekend day) collected in the 2 weeks before each assessment period using the validated multi-pass method. Recalls were collected from adolescents by telephone interview by trained dietitians using the Minnesota Nutrient Data Systems software (version 2.94, 2014). A DASH score was calculated according to Gunther et al (Hypertension 2009; 53: 6-12) modified to include a 10-point sodium component score. DASH score ranged from 0 to 90 with a higher score indicating greater DASH adherence.	change from baseline at immediately post-treatment (6 months)