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Completed

NCT Number: NCT00964483

Translating Dietary Trials Into the Community

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.

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Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DASH diet

Behavioral

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.

Delayed Intervention

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Gramercy Research Group
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Translating the Dietary Approaches to Stop Hypertension (DASH)Diet Into an Urban, African-American Community in Winston-Salem, North Carolina

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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