Diet and Hypertension Management in African Americans With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black race (self-identified)
- •≥21 years old
- •CKD defined as an eGFR of 30-59 ml/min/1.73m2
排除标准
- •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
结局指标
主要结局
Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm
时间窗: Up to 12 weeks
Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Clinic Mean Systolic Blood Pressure(Baseline to 12 weeks)
- Change in Body Weight(Baseline to 12 weeks)
- Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation(12 weeks to 24 weeks)
- Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation(12 weeks to 24 weeks)
- Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation(12 weeks to 24 weeks)
- Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)(Baseline to 12 weeks)