Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431288
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2007-02-01
Brief Title:
A Nutrition Intervention to Lower Blood Pressure in Adolescents
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Efficacy of a Nutrition Intervention Emphasizing Fruits Vegetables and Dairy to Lower Blood Pressure in Adolescents
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None