Clinical trial NCT00964483: Translating Dietary Trials Into the Community
Official title: Translating the Dietary Approaches to Stop Hypertension (DASH)Diet Into an Urban, African-American Community in Winston-Salem, North Carolina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Gramercy Research Group
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-08-25
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Dietary change from baseline.
timeFrame: Three Months
Secondary outcomes:
measure: Participation
timeFrame: three months
measure: Blood pressure
timeFrame: three months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Alain G Bertoni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gramercy Research Group
name: Melicia C Whitt-Glover, PhD
role: PRINCIPAL_INVESTIGATOR
References: