NCT00431288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

February 1, 2007

Last Update Submit

September 27, 2023

Conditions

Hypertension

Keywords

nutritionadolescent nutritionblood pressurehypertensiondiet therapypatient education

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    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 Outcomes (1)

  • Diet quality Indicators

    change from baseline diet quality indicators at immediately post-treatment (3 months)

Study Arms (2)

DASH intervention

EXPERIMENTAL

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)

Behavioral: diet high in fruits, vegetables, and dairy

Routine Care

OTHER

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: Routine nutrition care

Interventions

diet high in fruits, vegetables, and dairyBEHAVIORAL
Also known as: DASH dietary pattern
DASH intervention
Routine nutrition careOTHER
Also known as: Routine Care
Routine Care

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of prehypertension or stage 1 hypertension
  • age 11-18 years
  • english speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Related Publications (1)

  • 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.

    PMID: 18346503RESULT

MeSH Terms

Conditions

Hypertension

Interventions

FruitVegetables

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sarah C Couch, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All measurements were made in the Cincinnati Children's Hypertension Clinic by trained clinic staff blinded to treatment assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 5, 2007

Study Start

August 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)