Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Cincinnati |
---|---|
Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00585832 |
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.
Condition | Intervention |
---|---|
Hypertension Pre-Hypertension |
Behavioral: DASH-4-Teens Other: Routine Care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Modifying Dietary Behavior in Adolescents With Elevated Blood Pressure |
Estimated Enrollment: | 186 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
DASH-4-Teens Intervention
|
Behavioral: DASH-4-Teens
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
|
B
Routine Care
|
Other: Routine Care
individual in-person counseling sessions on guidelines consistent with the Fourth Pediatric Report of the National High Blood Pressure Education Program.
|
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.
Ages Eligible for Study: | 11 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sarah C Couch, Ph.D. | 513-558-7504 | couchsc@email.uc.edu |
Contact: Elaine M Urbina, MD | 513-636-1350 | Elaine.Urbina@cchmc.org |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Amy Pflum, M.Ed., RD 513-558-4048 Amy.Pflum@uc.edu | |
Contact: Sarah C Couch, Ph.D., RD (513) 558-7504 couchsc@email.uc.edu | |
Sub-Investigator: Elaine M Urbina, MD |
Principal Investigator: | Sarah C Couch, Ph.D. | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Sarah C. Couch ) |
Study ID Numbers: | 1R01HL088567-01A1, 1R01HL088567-01A1 |
Study First Received: | December 27, 2007 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00585832 |
Health Authority: | United States: Institutional Review Board |
hypertension pre-hypertension adolescents diet vascular function |
Vascular Diseases Hypertension |
Cardiovascular Diseases |