Clinical Trials Directory

Trials / Completed

CompletedNCT04084574

Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine cultural and disease-related barriers and facilitators to following the Dietary Approaches to Stop Hypertension (DASH) dietary pattern among Black Americans with moderate chronic kidney disease (CKD) and test the impact of a behavioral diet counseling intervention on DASH diet adherence, blood pressure, and CKD-relevant outcomes.

Detailed description

Excess cardiovascular disease (CVD) mortality among Black Americans with CKD is a significant US public health disparity. Compared to their White counterparts, Blacks develop CKD earlier in life and Blacks with CKD are 3 times more likely to progress to kidney failure necessitating dialysis or kidney transplantation, and are 1.5 times more likely to die prematurely from CVD. Hypertension, which is also more prevalent, more severe, and less often controlled in Blacks with CKD compared to Whites, is a leading cause of CKD and CVD, and a major contributor to the racial disparity in CVD mortality. Thus, improving hypertension in Blacks with CKD could have a profound positive impact on an important minority health issue. The DASH diet lowers BP and reduces CVD risk in patients with hypertension and has a greater effect on BP in Blacks compared to Whites. However, the effect of the DASH diet on BP in Blacks with CKD has not been established. First, investigators will conduct a qualitative study to identify self-perceived barriers and facilitators of DASH diet adherence among Blacks with moderate CKD. Then, investigators will conduct feasibility, acceptability, and preliminary efficacy testing of a disease-sensitive, culturally-appropriate diet counseling intervention on DASH adherence and blood pressure in Blacks with CKD. Prior to the clinical trial portion of this project Qualitative Focus Groups were held to identify self-perceived barriers and facilitators of DASH diet adherence among African Americans with CKD. Three to 4 groups of 6-8 participants were asked semi-structured questions to determine self-perceived sociocultural barriers and facilitators of DASH diet adherence and disease-specific factors that may influence their ability and willingness to follow a DASH-style diet. The information in the rest of this record pertains to the clinical trial portion of the project.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDASH diet counselingCulturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition

Timeline

Start date
2022-04-14
Primary completion
2023-08-08
Completion
2023-09-27
First posted
2019-09-10
Last updated
2025-01-06
Results posted
2025-01-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04084574. Inclusion in this directory is not an endorsement.