Chronic Kidney DiseaseNCT03299816
Five, Plus Nuts and Beans for Kidneys
A study testing Coaching DASH group (C-DASH) and Self-Shopping DASH group (S-DASH) in people with Chronic Kidney Disease and Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- Coaching DASH group (C-DASH) and Self-Shopping DASH group (S-DASH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2018to 8 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Baltimore Medical Campus
Baltimore, Maryland, 21202
About this study
Official title: Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- Coaching DASH group (C-DASH), Self-Shopping DASH group (S-DASH)
- Keywords
- Chronic Kidney Disease, Hypertension, Albuminuria, African Americans
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching DASH group (C-DASH)Behavioural
Also called Coaching DASH diet advice 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.
Self-Shopping DASH group (S-DASH)Behavioural
Also called Self-Shopping DASH diet advice 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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Shopping DASH group (S-DASH) | Active comparator | 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. Receives: Behavioral: Self-Shopping DASH group (S-DASH) |
| Coaching DASH group (C-DASH) | Experimental | 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. Receives: Behavioral: Coaching DASH group (C-DASH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Albumin Excretion From Baseline to 4 Months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
Measured: Baseline, 4 months
Secondary outcomes (3)
Change in Systolic Blood Pressure From Baseline to 4 Months
Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Measured: 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
Measured: 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).
Measured: Baseline, end of study (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start22 Feb 2018
- Primary completion22 Nov 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized controlled trial with two parallel arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Deidra Crews, MD, ScM, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299816
- Sponsor's protocol ID
- IRB00122943
- Other IDs
- 1U01MD010550-01
- Status last verified
- May 2023
- First submitted
- 18 Sep 2017
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share the Statistical Analysis Plan and Study Protocol.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03299816
- Acronym / sponsor ID
- IRB00122943
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- Chronic Kidney Disease, Hypertension, Albuminuria, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, randomized controlled trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Self-Shopping DASH group (S-DASH) | Active comparator | Behavioral: 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. |
| Coaching DASH group (C-DASH) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching DASH group (C-DASH)Also: Coaching DASH diet advice 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. | Behavioural | Coaching DASH group (C-DASH) |
| Self-Shopping DASH group (S-DASH)Also: Self-Shopping DASH diet advice 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. | Behavioural | Self-Shopping DASH group (S-DASH) |
Primary outcome
Change in Urinary Albumin Excretion From Baseline to 4 Months
Time frame: Baseline, 4 months
Urine samples will be collected for ACR (albumin-to-creatinine ratio).
3 secondary outcomes
Change in Systolic Blood Pressure From Baseline to 4 Months
Time frame: Baseline,4 months
Change in Systolic Blood Pressure From Baseline to 12 Months
Time frame: Baseline, end of study (approximately 12 months)
Change in Urinary Albumin Excretion From Baseline to 12 Months
Time frame: Baseline, end of study (approximately 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Plan to share the Statistical Analysis Plan and Study Protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deidra Crews, MD, ScM principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching DASH group (C-DASH) and Self-Shopping DASH group (S-DASH) in people with Chronic Kidney Disease and Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Albumin Excretion From Baseline to 4 Months (time frame: Baseline, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.