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A Nutrition Intervention to Lower Blood Pressure in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431288
First Posted: February 5, 2007
Last Update Posted: February 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Cincinnati
  Purpose
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 dietary knowledge, self-efficacy, diet quality and blood pressure post-treatment and at short-term follow-up in adolescents with hypertension.

Condition Intervention
Hypertension Behavioral: diet high in fruits, vegetables, and dairy Behavioral: Routine nutrition care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Efficacy of a Nutrition Intervention Emphasizing Fruits, Vegetables and Dairy to Lower Blood Pressure in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • knowledge, self-efficacy, diet quality (food groups and nutrients), blood pressure

Secondary Outcome Measures:
  • Body mass index (BMI) and BMI z score

Estimated Enrollment: 54
Study Start Date: August 2003
Estimated Study Completion Date: June 2006
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 dietary knowledge, self-efficacy, 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 nutrition knowledge, self-efficacy, dietary intake, and blood pressure. Our expectations are that the DASH intervention will significantly improve dietary knowledge, self-efficacy, 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431288


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Sarah C Couch, Ph.D. University of Cincinnati
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00431288     History of Changes
Other Study ID Numbers: AHA 0355332B
First Submitted: February 1, 2007
First Posted: February 5, 2007
Last Update Posted: February 5, 2007
Last Verified: February 2007

Keywords provided by University of Cincinnati:
nutrition
adolescent nutrition
blood pressure
hypertension
diet therapy
patient education

Additional relevant MeSH terms:
Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases