A Nutrition Intervention to Lower Blood Pressure in Adolescents

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00431288
First received: February 1, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Cincinnati

Additional 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
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014