Chronic Kidney Disease, Hypertension
Conditions
Keywords
Chronic Kidney Disease, Hypertension, Albuminuria, African Americans
Brief summary
This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.
Detailed description
This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD. 150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.
Interventions
BEHAVIORALCoaching DASH group (C-DASH)
Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
BEHAVIORALSelf-Shopping DASH group (S-DASH)
Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single center, randomized controlled trial with two parallel arms.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Self-identified African American race * Age 21 years or older * Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2. * Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months). * Must have a systolic blood pressure of \<=160 mmHg and a diastolic blood pressure of \<=100 mmHg (average of two visits) * Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.
Exclusion criteria
* Cardiovascular (CV) event within 6 months * Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2) * Unwillingness or inability to adopt a DASH-like diet * Consumes over 14 alcoholic drinks per week * Poorly controlled diabetes (Hemoglobin A1c \>9%). * Patients with a serum potassium \>4.6 milliequivalent (mEq) /L45 * Urine ACR ≥ 1,000 mg/g
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 4 Months | Baseline, 4 months | Urine samples will be collected for ACR (albumin-to-creatinine ratio). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 4 Months | Baseline,4 months | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl |
| Change in Systolic Blood Pressure From Baseline to 12 Months | Baseline, end of study (approximately 12 months) | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl |
| Change in Urinary Albumin Excretion From Baseline to 12 Months | Baseline, end of study (approximately 12 months) | Urine samples will be collected for ACR (albumin-to-creatinine ratio). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 1 Month | Baseline, 1 month | Urine samples will be collected for ACR (albumin-to-creatinine ratio). |
| Change in Systolic Blood Pressure From Baseline to 1 Month | Baseline, 1 month | Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coaching DASH Group (C-DASH) The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Coaching DASH group (C-DASH): Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance. | 70 |
| Self-Shopping DASH Group (S-DASH) The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.
Self-Shopping DASH group (S-DASH): Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases. | 72 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1: 4-month Intervention Period | Withdrawal by Subject | 1 | 0 |
| Phase 2: 12-month Follow-up Period | Lost to Follow-up | 2 | 3 |
| Phase 2: 12-month Follow-up Period | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Coaching DASH Group (C-DASH) | Total | Self-Shopping DASH Group (S-DASH) |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 13.7 | 61.1 years STANDARD_DEVIATION 12.8 | 62.7 years STANDARD_DEVIATION 11.7 |
| Baseline Urinary albumin-to-creatine (ACR) | 99.8 mg/g | 99.5 mg/g | 98.8 mg/g |
| Diabetes (Self-report) | 32 Participants | 63 Participants | 31 Participants |
| Diastolic Blood Pressure | 72.3 mmHg STANDARD_DEVIATION 10.6 | 73.3 mmHg STANDARD_DEVIATION 10.9 | 74.4 mmHg STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 140 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 140 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 70 Participants | 142 Participants | 72 Participants |
| Sex: Female, Male Female | 50 Participants | 90 Participants | 40 Participants |
| Sex: Female, Male Male | 20 Participants | 52 Participants | 32 Participants |
| Systolic Blood Pressure | 128.1 mmHg STANDARD_DEVIATION 14.4 | 129.4 mmHg STANDARD_DEVIATION 13.6 | 130.8 mmHg STANDARD_DEVIATION 12.8 |
| Urinary albumin-to-creatine ratio category >=300 mg/g | 11 Participants | 26 Participants | 15 Participants |
| Urinary albumin-to-creatine ratio category <30 mg/g | 6 Participants | 12 Participants | 6 Participants |
| Urinary albumin-to-creatine ratio category 30 to <300 mg/g | 53 Participants | 104 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 72 |
| other Total, other adverse events | 10 / 70 | 16 / 72 |
| serious Total, serious adverse events | 7 / 70 | 7 / 72 |
Outcome results
Primary
Change in Urinary Albumin Excretion From Baseline to 4 Months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, 4 months
Population: For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study and 2 were lost to follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Urinary Albumin Excretion From Baseline to 4 Months | -28.6 mg/g | Standard Error 12 |
| Self-Shopping DASH Group (S-DASH) | Change in Urinary Albumin Excretion From Baseline to 4 Months | -5.6 mg/g | Standard Error 11.6 |
p-value: 0.17Mixed effects regression
Secondary
Change in Systolic Blood Pressure From Baseline to 12 Months
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline, end of study (approximately 12 months)
Population: For C-DASH, 9 participants were excluded from analysis: 1 withdrew from Phase 2 of the study, 3 were lost to follow-up, 1 due to measurement error, 1 moved out of state, and 3 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 12 participants were excluded: 4 were lost to follow-up, 5 due to measurement error, and 3 were restricted from in-person data collection due to the pandemic.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Systolic Blood Pressure From Baseline to 12 Months | 1.5 mm Hg | Standard Error 2.3 |
| Self-Shopping DASH Group (S-DASH) | Change in Systolic Blood Pressure From Baseline to 12 Months | -1.6 mm Hg | Standard Error 2.3 |
p-value: 0.33Mixed effects regression
Secondary
Change in Systolic Blood Pressure From Baseline to 4 Months
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline,4 months
Population: For C-DASH, 4 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 1 was due to measurement error. For S-DASH, 5 participants were excluded: 4 were due to measurement error, and 1 due to an out-of-range baseline reading.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Systolic Blood Pressure From Baseline to 4 Months | -1.4 mm Hg | Standard Error 1.8 |
| Self-Shopping DASH Group (S-DASH) | Change in Systolic Blood Pressure From Baseline to 4 Months | 0.9 mm Hg | Standard Error 1.7 |
p-value: 0.36Mixed effects regression
Secondary
Change in Urinary Albumin Excretion From Baseline to 12 Months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, end of study (approximately 12 months)
Population: For C-DASH, 7 participants were excluded from analysis: 1 withdrew during Phase 2 of the study, 2 were lost to follow-up, and 4 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 8 participants were excluded: 3 were lost to follow-up, 1 sample was lost due to lab error, and 4 were restricted due to the pandemic.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Urinary Albumin Excretion From Baseline to 12 Months | -11.5 mg/g | Standard Error 14.1 |
| Self-Shopping DASH Group (S-DASH) | Change in Urinary Albumin Excretion From Baseline to 12 Months | -1.4 mg/g | Standard Error 13.7 |
p-value: 0.61Mixed effects regression
Other Pre-specified
Change in Systolic Blood Pressure From Baseline to 1 Month
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Time frame: Baseline, 1 month
Population: For C-DASH, 7 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 4 were due to measurement error. For S-DASH, 4 participants were excluded: 3 were due to measurement error, and 1 due to an out-of-range at baseline reading.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Systolic Blood Pressure From Baseline to 1 Month | -1.1 mm Hg | Standard Error 1.6 |
| Self-Shopping DASH Group (S-DASH) | Change in Systolic Blood Pressure From Baseline to 1 Month | -0.3 mm Hg | Standard Error 1.5 |
p-value: 0.75Mixed effects regression
Other Pre-specified
Change in Urinary Albumin Excretion From Baseline to 1 Month
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Time frame: Baseline, 1 month
Population: For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study, and 2 were lost to follow-up. For S-DASH, 1 participant was excluded from analysis due to an invalid urine sample.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | Change in Urinary Albumin Excretion From Baseline to 1 Month | -14.8 mg/g | Standard Error 10.1 |
| Self-Shopping DASH Group (S-DASH) | Change in Urinary Albumin Excretion From Baseline to 1 Month | -19.6 mg/g | Standard Error 9.8 |
p-value: 0.73Mixed effects regression