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Diet and Hypertension Management in African Americans With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084574
Recruitment Status : Suspended (Aim 1 enrollment and study activities have been completed. Aim 2 anticipated start date is 3/2021.)
First Posted : September 10, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases High Blood Pressure Behavioral: DASH diet counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Diet Counseling
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
Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition

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




Primary Outcome Measures :
  1. Number of Participants who complete the 12 week intervention program [ Time Frame: Up to 12 weeks ]
    Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm.

  2. Number of participants who complete data collection visits [ Time Frame: Up to 6 months ]
    Completion will be measured by the number of randomized participants who provide 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.

  3. Change in 24-hour mean systolic blood pressure during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.)

  4. Change in serum potassium concentration during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.)

  5. Change in 24 hour urine concentrations of sodium during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing sodium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)

  6. Change in 24 hour urine concentrations of potassium during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing potassium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)

  7. Change in 24 hour urine concentrations of phosphorus during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing phosphorus concentration levels (mg/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)

  8. Change in 24 hour urine concentrations of urea nitrogen during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing phosphorus concentration levels (g/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)


Secondary Outcome Measures :
  1. Change in clinic systolic blood pressure during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.)

  2. Change in body weight during treatment [ Time Frame: Baseline to 12 weeks ]
    Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.)

  3. Change in 24-hour mean systolic blood pressure 3-months post-treatment. [ Time Frame: 12 weeks to 24 weeks ]
    Change will be measured by comparing the 24-hour mean systolic blood pressures (mmHg) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)

  4. Change in body weight 3 months after intervention [ Time Frame: 12 weeks to 24 weeks ]
    Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)

  5. Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention. [ Time Frame: 12 weeks to 24 weeks ]
    Sustained DASH diet scores will be measured by comparing scores derived from 24-hour dietary recall data obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084574


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Crystal Tyson, M.D. Duke University
Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04084574    
Other Study ID Numbers: Pro00102823
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Racial disparities
Hypertension
Diet
Kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency