- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00431288
A Nutrition Intervention to Lower Blood Pressure in Adolescents
September 27, 2023 updated by: Sarah C. Couch, University of Cincinnati
Efficacy of a Nutrition Intervention Emphasizing Fruits, Vegetables and Dairy to Lower Blood Pressure in Adolescents
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DASH intervention
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)
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Other Names:
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Other: Routine Care
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)
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: change from baseline BP at immediately post-treatment (3 months)
|
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.
|
change from baseline BP at immediately post-treatment (3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet quality Indicators
Time Frame: change from baseline diet quality indicators at immediately post-treatment (3 months)
|
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.
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change from baseline diet quality indicators at immediately post-treatment (3 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah C Couch, Ph.D., University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2003
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
February 1, 2007
First Submitted That Met QC Criteria
February 1, 2007
First Posted (Estimated)
February 5, 2007
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHA 0355332B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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