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A Nutrition Intervention to Lower Blood Pressure in Adolescents

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diet high in fruits, vegetables, and dairy
Routine nutrition care
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring nutrition, adolescent nutrition, blood pressure, hypertension, diet therapy, patient education

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of prehypertension or stage 1 hypertension
  • age 11-18 years
  • english speaking

Exclusion Criteria:

  • stage 2 or secondary hypertension
  • target organ damage or symptomatic hypertension
  • type 1 or 2 diabetes
  • treated with anti-hypertensive medications or other blood pressure altering medications
  • are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium
  • 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 intervention

Routine Care

Arm Description

The DASH diet used in this intervention was slightly modified from the original version of the DASH diet for adults to more closely conform to the unique nutritional needs of adolescents. Details of the intervention have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501)

Routine care did not deviate from the nutrition counseling that was routinely given to all new patients at the Cincinnati Children's Hypertension Clinic. Details of routine care have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501)

Outcomes

Primary Outcome Measures

Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were performed with a mercury sphygmomanometer according to standardized procedures. SBP and DBP were measured two times and averaged. SBP and DBP z-scores were determined from these average measurements based on established norms.

Secondary Outcome Measures

Diet quality Indicators
Dietary intake was assessed with 3, 24-hour recalls collected over a 2-week period (2 weekdays and 1 weekend day) before each assessment visit using the validated multi-pass method. Recalls were collected from the adolescent by telephone interview and coded by a trained research dietitian. Adolescents were trained in the use of a 2-dimensional food portion size model to enhance recall of different food volumes and dimensions. Food recalls were analyzed for selected nutrients and servings of fruits, vegetables, low fat dairy foods and high sodium and fat containing foods using the Minnesota Nutrient Data Systems software (version 5.0, 2003). Indicators of diet quality were recorded as average number of daily servings of fruits, vegetables, low fat dairy foods and high fat and sodium containing foods.

Full Information

First Posted
February 1, 2007
Last Updated
September 27, 2023
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00431288
Brief Title
A Nutrition Intervention to Lower Blood Pressure in Adolescents
Official Title
Efficacy of a Nutrition Intervention Emphasizing Fruits, Vegetables and Dairy to Lower Blood Pressure in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2003 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of a 12-week, clinic-based, behavioral nutrition intervention emphasizing fruits, vegetables, and low fat dairy compared to routine nutrition care on changing diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.
Detailed Description
Among youth, hypertension is no longer a rare disease, affecting about 7 million children and adolescents. Numbers are increasing with the evolving pediatric obesity epidemic in the US. More adolescents than children have primary hypertension, which tracks 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. The purpose of this project is to evaluate the immediate and sustained impact of a 3-month clinic-based behavioral nutrition intervention emphasizing a diet high in fruits, vegetables, and low fat dairy, and low in fat and sodium (the DASH intervention) versus routine nutrition care on changing diet quality and blood pressure in adolescents with pre-hypertension or hypertension. The DASH intervention will include a printed participant manual, 1 individual counseling session with a dietitian, 4 mailings and 10 telephone calls on behavioral strategies to promote dietary change. Routine care will include 1 individual counseling session with a dietitian on dietary guidelines consistent with those of the National High Blood Pressure Education Program. Adolescents with prehypertension or hypertension will be randomly assigned to the DASH intervention or routine nutrition care after pre-treatment assessment. Post-treatment and at 3-month follow-up, outcome measures will be assessed including dietary intake and blood pressure. Our expectations are that the DASH intervention will significantly improve dietary quality and blood pressure in adolescents with elevated blood pressure compared to that observed as a result of routine nutrition care. The findings from this study are expected to improve the manner in which hypertension among adolescents is being treated in the clinical setting and contribute to the enhancement of the cardiovascular health of the target population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
nutrition, adolescent nutrition, blood pressure, hypertension, diet therapy, patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All measurements were made in the Cincinnati Children's Hypertension Clinic by trained clinic staff blinded to treatment assignment.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DASH intervention
Arm Type
Experimental
Arm Description
The DASH diet used in this intervention was slightly modified from the original version of the DASH diet for adults to more closely conform to the unique nutritional needs of adolescents. Details of the intervention have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501)
Arm Title
Routine Care
Arm Type
Other
Arm Description
Routine care did not deviate from the nutrition counseling that was routinely given to all new patients at the Cincinnati Children's Hypertension Clinic. Details of routine care have been published (Couch, SC et al. J Pediatrics 2008; 152: 494-501)
Intervention Type
Behavioral
Intervention Name(s)
diet high in fruits, vegetables, and dairy
Other Intervention Name(s)
DASH dietary pattern
Intervention Type
Other
Intervention Name(s)
Routine nutrition care
Other Intervention Name(s)
Routine Care
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were performed with a mercury sphygmomanometer according to standardized procedures. SBP and DBP were measured two times and averaged. SBP and DBP z-scores were determined from these average measurements based on established norms.
Time Frame
change from baseline BP at immediately post-treatment (3 months)
Secondary Outcome Measure Information:
Title
Diet quality Indicators
Description
Dietary intake was assessed with 3, 24-hour recalls collected over a 2-week period (2 weekdays and 1 weekend day) before each assessment visit using the validated multi-pass method. Recalls were collected from the adolescent by telephone interview and coded by a trained research dietitian. Adolescents were trained in the use of a 2-dimensional food portion size model to enhance recall of different food volumes and dimensions. Food recalls were analyzed for selected nutrients and servings of fruits, vegetables, low fat dairy foods and high sodium and fat containing foods using the Minnesota Nutrient Data Systems software (version 5.0, 2003). Indicators of diet quality were recorded as average number of daily servings of fruits, vegetables, low fat dairy foods and high fat and sodium containing foods.
Time Frame
change from baseline diet quality indicators at immediately post-treatment (3 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: clinical diagnosis of prehypertension or stage 1 hypertension age 11-18 years english speaking Exclusion Criteria: stage 2 or secondary hypertension target organ damage or symptomatic hypertension type 1 or 2 diabetes treated with anti-hypertensive medications or other blood pressure altering medications are unwilling to stop use of vitamins, minerals or antacids containing calcium or magnesium 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
45229-3039
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18346503
Citation
Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.
Results Reference
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A Nutrition Intervention to Lower Blood Pressure in Adolescents

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