Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases; High Blood Pressure
• Interventions: Behavioral: DASH diet counseling

• Registration Number: NCT04084574
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Study Start: 2022-04-14
• Primary Completion: 2023-08-08
• Study Completion: 2023-09-27
• Results First Submitted: 2024-07-24
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Black race (self-identified)
• ≥21 years old
• CKD defined as an eGFR of 30-59 ml/min/1.73m2

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Exclusion Criteria

• History of kidney transplant
• Pregnant of breast-feeding
• Risk factors for hyperkalemia including insulin-dependent diabetes mellitus, diabetes with poor blood glucose control (A1C >10), baseline serum potassium ≥4.8 mg/dl, and serum bicarbonate <18 mg/dl
• History of hypertension in the preceding 6 months defined as serum potassium greater than 5.1 mg/dl
• Risk for hypotension or severe hypertension (SBP <120 or ≥180 or DBP ≥110 mmHg)
• History of kidney transplant
• Lack of English language proficiency

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Diet Counseling	DASH diet counseling	Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake.
Standard of Care	DASH diet counseling	Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed.

Primary Outcome Measures

Name	Time	Method
Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm	Up to 12 weeks
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints	Baseline, 1 month, 3 months, 6 months	Number of randomized participants who provided blood and urine biospecimens, clinic and 24-hour ambulatory blood pressure measurements, and 24-hour dietary recall data during scheduled data collection visits at baseline, 1 month, 3 months, and 6 months.
Change in 24-hour Mean Systolic Blood Pressure	Baseline to 12 weeks	Change was measured by determining the difference in 24-hr mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value.
Change in Serum Potassium Concentration	Baseline to 12 weeks	Change was measured by determining the difference in serum potassium at 12 weeks (end of treatment) from baseline value.
Change in 24 Hour Urine Sodium Concentration	Baseline to 12 weeks	Change was measured by determining the difference in 24 hour urine sodium concentration at 12 weeks (end of treatment) from baseline value.
Change in 24 Hour Urine Phosphorus Concentration	Baseline to 12 weeks	Change was measured by determining the difference in 24 hour urine phosphorus concentration at 12 weeks (end of treatment) from baseline value.
Change in 24 Hour Urine Urea Nitrogen Concentration	Baseline to 12 weeks	Change was measured by determining the difference in 24 hour urine urea nitrogen concentration at 12 weeks (end of treatment) from baseline value.

Secondary Outcome Measures

Name	Time	Method
Change in Clinic Mean Systolic Blood Pressure	Baseline to 12 weeks	Change was measured by determining the difference in clinic mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value.
Change in Body Weight	Baseline to 12 weeks	Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value.
Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation	12 weeks to 24 weeks	Change was measured by determining the difference in mean clinic systolic blood pressure (mmHg) obtained at 24 weeks from 12 weeks.
Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation	12 weeks to 24 weeks	Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks.
Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation	12 weeks to 24 weeks	Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality.
Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)	Baseline to 12 weeks	Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States