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Translating Dietary Trials Into the Community

This study has been completed.
Sponsor:
Collaborator:
Gramercy Research Group
Information provided by (Responsible Party):
Alain G. Bertoni, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00964483
First received: August 24, 2009
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Behavioral: DASH diet
Behavioral: Delayed Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Translating the Dietary Approaches to Stop Hypertension (DASH)Diet Into an Urban, African-American Community in Winston-Salem, North Carolina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Dietary change from baseline. [ Time Frame: Three Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participation [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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.
Behavioral: Delayed Intervention
The participants will receive a guide written by NHLBI entitled, "Your Guide to Lowering Blood Pressure."

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964483

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Gramercy Research Group
Investigators
Principal Investigator: Alain G Bertoni, MD, MPH Wake Forest University
Principal Investigator: Melicia C Whitt-Glover, PhD Gramercy Research Group
  More Information

No publications provided

Responsible Party: Alain G. Bertoni, Associate Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00964483     History of Changes
Other Study ID Numbers: 5R21HL091303-02, 5R21HL091303-02
Study First Received: August 24, 2009
Last Updated: September 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013