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Translating Dietary Trials Into the Community

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet
Delayed Intervention
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DASH materials

Delayed intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dietary change from baseline.

Secondary Outcome Measures

Participation
Blood pressure

Full Information

First Posted
August 24, 2009
Last Updated
July 30, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Gramercy Research Group, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00964483
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Gramercy Research Group, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DASH materials
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DASH diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Intervention
Intervention Description
The participants will receive a guide written by NHLBI entitled, "Your Guide to Lowering Blood Pressure."
Primary Outcome Measure Information:
Title
Dietary change from baseline.
Time Frame
Three Months
Secondary Outcome Measure Information:
Title
Participation
Time Frame
three months
Title
Blood pressure
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain G Bertoni, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melicia C Whitt-Glover, PhD
Organizational Affiliation
Gramercy Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Translating Dietary Trials Into the Community

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