An interventional study of Coaching DASH group (C-DASH) and Self-Shopping DASH group (S-DASH) in Chronic Kidney Disease and Hypertension, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Behavioral: Self-Shopping DASH group (S-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.
Behavioral: 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.
Also known as: Coaching DASH diet advice group (C-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.
Also known as: Self-Shopping DASH diet advice Group (S-DASH)
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
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
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)
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)
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
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
| Milestone | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Started | 70 | 72 |
| Completed | 69 | 72 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Started | 52 | 56 |
| Completed | 49 | 53 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 3 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 4 Months | -28.6 ± 12.0 | -5.6 ± 11.6 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 4 Months | -1.4 ± 1.8 | 0.9 ± 1.7 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 12 Months | 1.5 ± 2.3 | -1.6 ± 2.3 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 12 Months | -11.5 ± 14.1 | -1.4 ± 13.7 |
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
| mg/g | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Urinary Albumin Excretion From Baseline to 1 Month | -14.8 ± 10.1 | -19.6 ± 9.8 |
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
| mm Hg | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline to 1 Month | -1.1 ± 1.6 | -0.3 ± 1.5 |
Collected over The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coaching DASH Group (C-DASH) | 0/70 (0%) | 7/70 (10%) | 10/70 (14.3%) |
| Self-Shopping DASH Group (S-DASH) | 0/72 (0%) | 7/72 (9.7%) | 16/72 (22.2%) |
| Event | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Abdominal PainGastrointestinal disorders | 1/70 | 0/72 |
| Angioneurotic edemaInjury, poisoning and procedural complications | 1/70 | 0/72 |
| Acute kidney failureRenal and urinary disorders | 1/70 | 0/72 |
| Chronic pancreatitisGastrointestinal disorders | 1/70 | 0/72 |
| COVID-19Infections and infestations | 1/70 | 0/72 |
| Diabetes mellitus with ketoacidosisEndocrine disorders | 1/70 | 0/72 |
| Mechanical complication of ventricular intracranial (communicating) shuntNervous system disorders | 1/70 | 0/72 |
| Moderate persistent asthma with (acute) exacerbationRespiratory, thoracic and mediastinal disorders | 1/70 | 0/72 |
| Acute Kidney InjuryRenal and urinary disorders | 1/70 | 0/72 |
| Angina pectorisVascular disorders | 1/70 | 0/72 |
| Event | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) |
|---|---|---|
| Hypertensive UrgencyVascular disorders | 3/70 | 10/72 |
| HypokalemiaMetabolism and nutrition disorders | 7/70 | 6/72 |
| Age, Continuous(years) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 59.7 ± 13.7 | 62.7 ± 11.7 | 61.1 ± 12.8 |
| Sex: Female, Male(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Female | 50 | 40 | 90 |
| Male | 20 | 32 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 69 | 71 | 140 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 69 | 71 | 140 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| United States | 70 | 72 | 142 |
| Baseline Urinary albumin-to-creatine (ACR)(mg/g) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 99.8 (49.0 to 234.5) | 98.8 (47.3 to 236.5) | 99.5 (4.08 to 234.5) |
| Systolic Blood Pressure(mmHg) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 128.1 ± 14.4 | 130.8 ± 12.8 | 129.4 ± 13.6 |
| Diastolic Blood Pressure(mmHg) | Coaching DASH Group (C-DASH) | Self-Shopping DASH Group (S-DASH) | Total |
|---|---|---|---|
| Mean | 72.3 ± 10.6 | 74.4 ± 11.2 | 73.3 ± 10.9 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Plan to share the Statistical Analysis Plan and Study Protocol.
Supporting information: Study protocol, Sap
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