Multi-component Lifestyle Intervention to Improve Outcomes in Black Adults with Chronic Kidney Disease

/Abstract: Excess cardiovascular disease (CVD) mortality among Black Americans with chronic kidney disease (CKD) is a significant US public health disparity. Compared to their White counterparts, Black Americans develop kidney disease earlier in life, are 3.5-fold more likely to develop kidney failure, and are 1.5-fold more likely to die prematurely from CVD. Uncontrolled hypertension, which is also more prevalent and more severe in Black adults with CKD compared to Whites, is a major risk determinant of CKD progression and CVD mortality. Therefore, improving hypertension control rates in Black adults with CKD could have a profound positive impact on an important minority health challenge. Multi-component lifestyle modification, including healthful dietary changes, increased physical activity and weight management, is proven to lower BP in adults with normal kidney function. However, the impact of multi-component lifestyle modification on BP in adults with CKD is yet to be determined. The quality of evidence from the few existing randomized controlled lifestyle intervention trials involving patients with CKD is poor due to a lack of power to detect changes in BP and kidney function. Moreover, Black adults and patients with advanced CKD have been historically under- represented in such trials despite each sharing an excess burden of poor kidney and CVD outcomes. It cannot be assumed that lifestyle modification will effectively lower BP in patients with advanced CKD considering they have a pathophysiology that causes their BP to be more severely elevated and less responsive to standard anti-hypertensive medications than patients with normal kidney function. Culturally-adapted strategies may also be necessary to improve hypertension and kidney health disparities among Black adults. The goal of this study is to conduct an adequately powered randomized controlled trial to determine whether a multi- component lifestyle intervention improves BP in Black adults with advanced CKD. We will randomize 152 adults with an estimated glomerular filtration rate of 15-44 ml/min/1.73m2 to either: 1) a 4-month lifestyle intervention involving weekly culturally-adapted, low-sodium DASH diet counseling, thrice-weekly supervised exercise, and weight management delivered in a cardiac rehabilitation setting, or 2) a usual care control condition involving a one-time 30-minute low sodium diet consultation plus an exercise prescription to self- implement without study support. Our primary outcome will be change in clinic systolic BP (SBP) from baseline at 4 months. Our secondary outcomes will be changes at 4 months in 24-hour ambulatory SBP, DASH diet score, urinary sodium-to-potassium ratio, peak oxygen consumption, and 24-hour urine albumin excretion. We will also assess sustainability of the intervention effect 12 months post-randomization and explore the effect of individual level and engagement level factors on variability in response at 4 months and 12 months. Findings from our study will have important implications for expanding BP management options for an understudied racial subgroup and a CKD sub-population using a strategy that is feasible for future implementation. Project Number: 1R61HL178691-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Crystal Tyson | Institution: DUKE UNIVERSITY, DURHAM, NC | Award Amount: $772,621 | Activity Code: R61 | Study Section: NHLBI Single-Site and Pilot Clinical Trials Study Section[SSPT (JA)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R61HL17869101