Clinical trial NCT04084574: Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Official title: Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
High Blood Pressure
Keywords: Racial disparities
Hypertension
Diet
Kidney disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm
timeFrame: Up to 12 weeks
measure: Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in 24-hour Mean Systolic Blood Pressure
timeFrame: Baseline to 12 weeks
measure: Change in Serum Potassium Concentration
timeFrame: Baseline to 12 weeks
measure: Change in 24 Hour Urine Sodium Concentration
timeFrame: Baseline to 12 weeks
measure: Change in 24 Hour Urine Phosphorus Concentration
timeFrame: Baseline to 12 weeks
measure: Change in 24 Hour Urine Urea Nitrogen Concentration
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Clinic Mean Systolic Blood Pressure
timeFrame: Baseline to 12 weeks
measure: Change in Body Weight
timeFrame: Baseline to 12 weeks
measure: Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation
timeFrame: 12 weeks to 24 weeks
measure: Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation
timeFrame: 12 weeks to 24 weeks
measure: Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation
timeFrame: 12 weeks to 24 weeks
measure: Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Crystal Tyson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tyson CC, Davenport CA, Lin PH, Scialla JJ, Hall R, Diamantidis CJ, Lunyera J, Bhavsar N, Rebholz CM, Pendergast J, Boulware LE, Svetkey LP. DASH Diet and Blood Pressure Among Black Americans With and Without CKD: The Jackson Heart Study. Am J Hypertens. 2019 Sep 24;32(10):975-982. doi: 10.1093/ajh/hpz090.
citation: Tyson CC, Barnhart H, Sapp S, Poon V, Lin PH, Svetkey LP. Ambulatory blood pressure in the dash diet trial: Effects of race and albuminuria. J Clin Hypertens (Greenwich). 2018 Feb;20(2):308-314. doi: 10.1111/jch.13170. Epub 2018 Jan 31.
citation: Tyson CC, Lin PH, Corsino L, Batch BC, Allen J, Sapp S, Barnhart H, Nwankwo C, Burroughs J, Svetkey LP. Short-term effects of the DASH diet in adults with moderate chronic kidney disease: a pilot feeding study. Clin Kidney J. 2016 Aug;9(4):592-8. doi: 10.1093/ckj/sfw046. Epub 2016 Jun 5.
citation: Tyson CC, Kuchibhatla M, Patel UD, Pun PH, Chang A, Nwankwo C, Joseph MA, Svetkey LP. Impact of Kidney Function on Effects of the Dietary Approaches to Stop Hypertension (Dash) Diet. J Hypertens (Los Angel). 2014;3:1000168. doi: 10.4172/2167-1095.1000168.