Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure (DASH-4-Teens)
Primary Purpose
Hypertension, Pre-Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH-4-Teens
Routine Care
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, pre-hypertension, adolescents, diet, vascular function
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
DASH-4-Teens Intervention
Routine Care
Arm Description
DASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Routine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT00585832
First Posted
December 27, 2007
Last Updated
June 13, 2022
Sponsor
University of Cincinnati
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00585832
Brief Title
Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
Acronym
DASH-4-Teens
Official Title
Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pre-Hypertension
Keywords
hypertension, pre-hypertension, adolescents, diet, vascular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DASH-4-Teens Intervention
Arm Type
Experimental
Arm Description
DASH-4-Teens Intervention is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Arm Title
Routine Care
Arm Type
Other
Arm Description
Routine Care is described in detail in Couch, SC et al. Hypertension 2021: 77:241-251.
Intervention Type
Behavioral
Intervention Name(s)
DASH-4-Teens
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.
Primary Outcome Measure Information:
Title
Blood Pressure (BP)
Description
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.
Time Frame
change from baseline BP at immediately post-treatment (6 months)
Secondary Outcome Measure Information:
Title
Vascular Function
Description
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).
Time Frame
change from baseline at immediately post-treatment (6 months)
Title
DASH dietary adherence
Description
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.
Time Frame
change from baseline at immediately post-treatment (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah C Couch, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
IPD Sharing Time Frame
through May 2023.
IPD Sharing Access Criteria
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Citations:
PubMed Identifier
33190559
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.
Results Reference
result
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Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure
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