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Completed

NCT Number: NCT04084574

Diet and Hypertension Management in African Americans With Chronic Kidney Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

DASH diet counseling

Behavioral

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

Primary outcomes

  1. Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm

    Time frame: Up to 12 weeks

  2. Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints

    Time frame: 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.

  3. Change in 24-hour Mean Systolic Blood Pressure

    Time frame: 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.

  4. Change in Serum Potassium Concentration

    Time frame: Baseline to 12 weeks

    Change was measured by determining the difference in serum potassium at 12 weeks (end of treatment) from baseline value.

  5. Change in 24 Hour Urine Sodium Concentration

    Time frame: 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.

  6. Change in 24 Hour Urine Phosphorus Concentration

    Time frame: 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.

  7. Change in 24 Hour Urine Urea Nitrogen Concentration

    Time frame: 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 outcomes

  1. Change in Clinic Mean Systolic Blood Pressure

    Time frame: 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.

  2. Change in Body Weight

    Time frame: Baseline to 12 weeks

    Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value.

  3. Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation

    Time frame: 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.

  4. Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation

    Time frame: 12 weeks to 24 weeks

    Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks.

  5. Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation

    Time frame: 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.

  6. Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
Jan 6, 2025

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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