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CompletedNCT00964483Updated Aug 1, 2018

Translating Dietary Trials Into the Community

An interventional study of DASH diet and Delayed Intervention in Hypertension, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

Hypertension (HTN) is a prevalent risk factor for cardiovascular, cerebrovascular, and renal disease, and disproportionately affects African Americans (AA). Although HTN awareness and treatment rates among AA are similar to, or exceed non-Hispanic whites, control of HTN among AAs remains inadequate. Randomized clinical trials have demonstrated the effectiveness of lifestyle measures in lowering BP, including the Dietary Approaches to Stop Hypertension (DASH) diet, which lowers systolic BP 6-14 mmHg. DASH calls for increased consumption of fruits, vegetables, and low fat dairy, and decreased saturated fat and sodium intake. There is limited evidence that DASH has been widely adopted by the public and AA from lower income communities may be less able to adopt DASH as currently disseminated due to barriers related to income, education, attitudes about foods, health beliefs, and neighborhood availability of healthier foods. We propose to utilize quantitative and qualitative research techniques (including focus groups and surveys) to assess environmental, intra-personal, interpersonal and cultural factors that could affect the translation of the DASH diet in a low-income AA community, then utilize the knowledge gathered to adapt existing intervention strategies and tools. These will provide the materials for a randomized three month pilot lifestyle intervention implementing the DASH diet. The 40 participants will be aged 21+ and have pre-HTN or HTN with blood pressure between 120-150/80-95 mmHg on 0,1 or 2 antihypertensive agents, and will be AA residents of two zip codes in Winston-Salem (a lower-income area whose population is significantly minority).

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 25 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    DASH materials

    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

  • Active comparator
    Delayed intervention

    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 diet · Behavioral: Delayed Intervention

Interventions

  • BehavioralDASH diet

    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.

  • BehavioralDelayed Intervention

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

06

What researchers measure

Primary outcomes

  1. Dietary change from baseline.

    Time frame: Three Months

Secondary outcomes

  1. Participation

    Time frame: three months

  2. Blood pressure

    Time frame: three months

07

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00964483
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Gramercy Research Group, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Aug 25, 2009
Start date
Jan 2010
Primary completion
Jul 2010
Completion
Sep 2010
Last update
Aug 1, 2018

Study contacts

Alain G Bertoni, MD, MPH
principal investigator · Wake Forest University Health Sciences
Melicia C Whitt-Glover, PhD
principal investigator · Gramercy Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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