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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinic Mean Systolic Blood Pressure | Change was measured by determining the difference in clinic mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value. | Baseline to 12 weeks |
| Change in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crystal Tyson, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31187128 | Background | 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. | |
| 29384243 | Background |
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No IPD will be available to other researchers
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Of 204 individuals who completed the pre-screening survey, 158 were eligible for further screening, 86 consented to the study, and 31 met final inclusion criteria and were randomized to the intervention or control group.
Patients at a single academic medical center were recruited by invitation via their electronic patient portal or mailed letter.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition |
| FG001 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm | Only relevant to the Behavioral Diet Counseling arm. | Posted | Mean | Standard Deviation | sessions per participant | Up to 12 weeks |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Tyson, MD, MHS | Duke University | 919-660-6671 | crystal.simpson@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2023 | Jul 24, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2023 | Jan 11, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 |
Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value.
| Baseline to 12 weeks |
| Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in mean clinic systolic blood pressure (mmHg) obtained at 24 weeks from 12 weeks. | 12 weeks to 24 weeks |
| Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks. | 12 weeks to 24 weeks |
| Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality. | 12 weeks to 24 weeks |
| Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment) | Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality. | Baseline to 12 weeks |
| 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. |
| 27478603 | 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. |
| 26380159 | 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. |
| Relocated out of state |
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| BG001 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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. | Posted | Count of Participants | Participants | Baseline, 1 month, 3 months, 6 months |
|
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| Primary | 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. | Data not collected on 3 participants in the Behavioral Diet Counseling arm and 4 participants in the Standard of Care arm. | Posted | Mean | Standard Deviation | mmHg | Baseline to 12 weeks |
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| Primary | Change in Serum Potassium Concentration | Change was measured by determining the difference in serum potassium at 12 weeks (end of treatment) from baseline value. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmol/L | Baseline to 12 weeks |
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|
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| Primary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmol/L/day | Baseline to 12 weeks |
|
|
|
| Primary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmol/L/day | Baseline to 12 weeks |
|
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| Primary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mg/dL/day | Baseline to 12 weeks |
|
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| Primary | 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. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mcg/mL | Baseline to 12 weeks |
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| Secondary | Change in Clinic Mean Systolic Blood Pressure | Change was measured by determining the difference in clinic mean systolic blood pressure (mmHg) obtained at 12 weeks (end of treatment) from baseline value. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmHg | Baseline to 12 weeks |
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| Secondary | Change in Body Weight | Change was measured by determining the difference in body weight obtained at 12 weeks (end of treatment) from baseline value. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | kg | Baseline to 12 weeks |
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| Secondary | Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in mean clinic systolic blood pressure (mmHg) obtained at 24 weeks from 12 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | mmHg | 12 weeks to 24 weeks |
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| Secondary | Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in body weight obtained at 24 weeks from 12 weeks. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | kg | 12 weeks to 24 weeks |
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| Secondary | Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation | Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks to 24 weeks |
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| Secondary | Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment) | Change was measured by determining the difference in DASH diet score obtained at 24 weeks from 12 weeks. The DASH score, ranging from 8 to 40 points with eight components, focuses on food and nutrients for managing hypertension. The eight components are "fruits", "vegetables", "nuts and legumes", "whole grains", "low-fat dairy", "sodium", "red and processed meats", and "sweetened beverages". A higher score indicates better diet quality. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
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| 0 |
| 16 |
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | 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. DASH diet counseling: Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition | 0 | 15 | 0 | 15 | 3 | 15 |
| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment | Serum creatinine >30% at previous visit or occurrence of adverse event involving 'acute kidney injury' |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | Serum potassium 5.1-5.5 mmol/L |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | Serum potassium 5.6-5.9 mmol/L |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 3 months |
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| 6 months |
|