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Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases, High Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet counseling
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Racial disparities, Hypertension, Diet, Kidney disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Behavioral Diet Counseling

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants who complete the 12 week intervention program
Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm.
Number of participants who complete data collection visits
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.
Change in 24-hour mean systolic blood pressure during treatment
Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.)
Change in serum potassium concentration during treatment
Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.)
Change in 24 hour urine concentrations of sodium during treatment
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.)
Change in 24 hour urine concentrations of potassium during treatment
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.)
Change in 24 hour urine concentrations of phosphorus during treatment
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.)
Change in 24 hour urine concentrations of urea nitrogen during treatment
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

Change in clinic systolic blood pressure during treatment
Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.)
Change in body weight during treatment
Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.)
Change in 24-hour mean systolic blood pressure 3-months post-treatment.
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.)
Change in body weight 3 months after intervention
Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)
Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention.
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.)

Full Information

First Posted
September 3, 2019
Last Updated
March 6, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04084574
Brief Title
Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Official Title
Diet and Hypertension Management in African Americans With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, High Blood Pressure
Keywords
Racial disparities, Hypertension, Diet, Kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Diet Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DASH diet counseling
Intervention Description
Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
Primary Outcome Measure Information:
Title
Number of Participants who complete the 12 week intervention program
Description
Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm.
Time Frame
Up to 12 weeks
Title
Number of participants who complete data collection visits
Description
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.
Time Frame
Up to 6 months
Title
Change in 24-hour mean systolic blood pressure during treatment
Description
Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.)
Time Frame
Baseline to 12 weeks
Title
Change in serum potassium concentration during treatment
Description
Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.)
Time Frame
Baseline to 12 weeks
Title
Change in 24 hour urine concentrations of sodium during treatment
Description
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.)
Time Frame
Baseline to 12 weeks
Title
Change in 24 hour urine concentrations of potassium during treatment
Description
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.)
Time Frame
Baseline to 12 weeks
Title
Change in 24 hour urine concentrations of phosphorus during treatment
Description
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.)
Time Frame
Baseline to 12 weeks
Title
Change in 24 hour urine concentrations of urea nitrogen during treatment
Description
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.)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in clinic systolic blood pressure during treatment
Description
Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.)
Time Frame
Baseline to 12 weeks
Title
Change in body weight during treatment
Description
Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.)
Time Frame
Baseline to 12 weeks
Title
Change in 24-hour mean systolic blood pressure 3-months post-treatment.
Description
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.)
Time Frame
12 weeks to 24 weeks
Title
Change in body weight 3 months after intervention
Description
Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)
Time Frame
12 weeks to 24 weeks
Title
Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention.
Description
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.)
Time Frame
12 weeks to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Redd, M.Ed
Phone
919-684-9545
Email
cindy.redd@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Tyson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Redd, M.Ed
Phone
919-684-9545
Email
cindy.redd@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be available to other researchers
Citations:
PubMed Identifier
31187128
Citation
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.
Results Reference
background
PubMed Identifier
29384243
Citation
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.
Results Reference
background
PubMed Identifier
27478603
Citation
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.
Results Reference
background
PubMed Identifier
26380159
Citation
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.
Results Reference
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Diet and Hypertension Management in African Americans With Chronic Kidney Disease

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