Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Conditions
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Chronic Kidney Diseases, High Blood Pressure

Intervention / Treatment
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* Behavioral: DASH diet counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Diet Counseling<br>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. | Behavioral: DASH diet counseling<br>* Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition<br>|
| Other: Standard of Care<br>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. | Behavioral: DASH diet counseling<br>* Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who complete the 12 week intervention program | Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm. | Up to 12 weeks | 
| Number of participants who complete data collection visits | Completion will be measured by the number of randomized participants who provide 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. | Up to 6 months | 
| Change in 24-hour mean systolic blood pressure during treatment | Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in serum potassium concentration during treatment | Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in 24 hour urine concentrations of sodium during treatment | Change will be measured by comparing sodium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in 24 hour urine concentrations of potassium during treatment | Change will be measured by comparing potassium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in 24 hour urine concentrations of phosphorus during treatment | Change will be measured by comparing phosphorus concentration levels (mg/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in 24 hour urine concentrations of urea nitrogen during treatment | Change will be measured by comparing phosphorus concentration levels (g/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.) | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinic systolic blood pressure during treatment | Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in body weight during treatment | Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.) | Baseline to 12 weeks | 
| Change in 24-hour mean systolic blood pressure 3-months post-treatment. | Change will be measured by comparing the 24-hour mean systolic blood pressures (mmHg) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.) | 12 weeks to 24 weeks | 
| Change in body weight 3 months after intervention | Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.) | 12 weeks to 24 weeks | 
| Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention. | Sustained DASH diet scores will be measured by comparing scores derived from 24-hour dietary recall data obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.) | 12 weeks to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Racial disparities, Hypertension, Diet, Kidney disease