NCT00964483

Brief Summary

A diet that is rich in fruits, vegetables, and low fat dairy foods is known to lower blood pressure in adults. This research project seeks to promote the adoption of the Dietary Approaches to Stop Hypertension(DASH)eating pattern by African American adults with hypertension or prehypertension living in a lower income minority community. The randomized trial phase of this project will test a group-based intervention using materials adopted from prior studies and tailored to the community of interest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2010

Shorter than P25 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

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

August 24, 2009

Last Update Submit

July 30, 2018

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Dietary change from baseline.

    Three Months

Secondary Outcomes (2)

  • Participation

    three months

  • Blood pressure

    three months

Study Arms (2)

DASH materials

EXPERIMENTAL

Participant randomized to a 12-week, group-based lifestyle intervention using modified DASH materials and intervention delivery approaches to help them adopt the DASH diet. Intervention content will be designed to provide participants with the knowledge and skills to adopt the DASH eating pattern, specifically to increase fruit, vegetable, and low-fat dairy intake, and to decrease saturated fats and sodium.

Behavioral: DASH diet

Delayed intervention

ACTIVE COMPARATOR

The intervention participants will receive an NHLBI brochure entitled "Your Guide to Lowering Blood Pressure." They will then receive the modified DASH materials and the intervention at the end of the study, following the intervention group's completion of the study.

Behavioral: DASH dietBehavioral: Delayed Intervention

Interventions

DASH dietBEHAVIORAL

The intervention will consist of a 12-week pilot trial in which participants will be given intervention materials tailored to their community, focusing on DASH. Intervention content will be designed to provide participants with the knowledge and skills to adopt the DASH eating pattern, specifically to increase fruit, vegetable, and low-fat dairy intake, and to decrease saturated fats and sodium. They will follow this diet for 12 weeks.

DASH materialsDelayed intervention
Delayed InterventionBEHAVIORAL

The participants will receive a guide written by NHLBI entitled, "Your Guide to Lowering Blood Pressure."

Delayed intervention

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being African American
  • Age 21 years or older
  • Residing in zip code 27105 or 27101
  • Formal education less than 4-year college degree
  • Blood pressure between 120/80 mmHg and 150/95 mmHg, inclusive (patients on BP lowering drugs eligible if BP is in above range)
  • Willing to provide informed consent
  • Able to participate in English

You may not qualify if:

  • Clinical history of congestive heart failure
  • Clinical history of diabetes, or newly diagnosed diabetes at screening
  • Clinical history of renal insufficiency (Stage 3 or higher chronic kidney disease)
  • BMI less than or equal to 18.5 kg/m2 or greater than or equal to 45.0 kg/m2
  • Pregnancy
  • Non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Alain G Bertoni, MD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Melicia C Whitt-Glover, PhD

    Gramercy Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)