Diet and Hypertension Management in African Americans With Chronic Kidney Disease

NCT04084574 | Completed Results DMC

• 1 other identifier: Pro00102823
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; High Blood Pressure

Keywords

Racial disparities; Hypertension; Diet; Kidney disease

Outcome Measures

Primary Outcomes (7)

• Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline to 12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Behavioral Diet Counseling

EXPERIMENTAL

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

Standard of Care

OTHER

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

Interventions

DASH diet counseling BEHAVIORAL

Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition

Behavioral Diet Counseling; Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black race (self-identified)
• ≥21 years old
• CKD defined as an eGFR of 30-59 ml/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 31187128 BACKGROUND

• 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.

  PMID: 29384243 BACKGROUND

• 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.

  PMID: 27478603 BACKGROUND

• 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.

  PMID: 26380159 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Crystal Tyson, MD, MHS
• Organization: Duke University

crystal.simpson@duke.edu

919-660-6671

Study Officials

• Crystal Tyson, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 10, 2019
• Study Start: April 14, 2022
• Primary Completion: August 8, 2023
• Study Completion: September 27, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)