A Nutrition Intervention to Lower Blood Pressure in Adolescents

NCT ID: NCT00431288

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2006-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

diet high in fruits, vegetables, and dairy

Intervention Type: BEHAVIORAL

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)

Group Type: OTHER

Routine nutrition care

Intervention Type: OTHER

Interventions

diet high in fruits, vegetables, and dairy

Intervention Type: BEHAVIORAL

Routine nutrition care

Intervention Type: OTHER

Other Intervention Names

DASH dietary pattern; Routine Care

Eligibility 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Sarah C. Couch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah C Couch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.

Reference Type: RESULT

PMID: 18346503 (View on PubMed)

Other Identifiers

AHA 0355332B

Identifier Type: -

Identifier Source: org_study_id