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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Duke University Medical Center
Durham, North Carolina, United States
Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm
Time frame: Up to 12 weeks
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints
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.
Time frame: Baseline, 1 month, 3 months, 6 months
Change in 24-hour Mean Systolic Blood Pressure
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.
Time frame: Baseline to 12 weeks
Change in Serum Potassium Concentration
Change was measured by determining the difference in serum potassium at 12 weeks (end of treatment) from baseline value.
Time frame: Baseline to 12 weeks
Change in 24 Hour Urine Sodium Concentration
Change was measured by determining the difference in 24 hour urine sodium concentration at 12 weeks (end of treatment) from baseline value.
Time frame: Baseline to 12 weeks
Change in 24 Hour Urine Phosphorus Concentration
Change was measured by determining the difference in 24 hour urine phosphorus concentration at 12 weeks (end of treatment) from baseline value.
Time frame: Baseline to 12 weeks
Change in 24 Hour Urine Urea Nitrogen Concentration
Change was measured by determining the difference in 24 hour urine urea nitrogen concentration at 12 weeks (end of treatment) from baseline value.
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Time frame: Baseline to 12 weeks
Change in Clinic Mean Systolic Blood Pressure
Change was measured by determining the difference in clinic mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value.
Time frame: Baseline to 12 weeks
Change in Body Weight
Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value.
Time frame: Baseline to 12 weeks
Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation
Change was measured by determining the difference in mean clinic systolic blood pressure (mmHg) obtained at 24 weeks from 12 weeks.
Time frame: 12 weeks to 24 weeks
Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation
Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks.
Time frame: 12 weeks to 24 weeks
Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation
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.
Time frame: 12 weeks to 24 weeks
Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)
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.
Time frame: Baseline to 12 weeks