Five, Plus Nuts and Beans for Kidneys
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|ClinicalTrials.gov Identifier: NCT03299816|
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Hypertension||Behavioral: Coaching DASH group (C-DASH) Behavioral: Self-Shopping DASH group (S-DASH)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single center, randomized controlled trial with two parallel arms.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||September 22, 2021|
|Estimated Study Completion Date :||September 22, 2021|
Active Comparator: 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.
Behavioral: 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.
Other Name: Self-Shopping DASH diet advice Group (S-DASH)
Experimental: 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.
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.
Other Name: Coaching DASH diet advice group (C-DASH)
- Change in Albuminuria from Baseline to 1 month [ Time Frame: Baseline, 1 month ]Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.
- Change in Albuminuria from Baseline to 4 months [ Time Frame: Baseline, 4 months ]Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.
- Change in Albuminuria from Baseline to end of study [ Time Frame: Baseline, end of study (approximately 12 months) ]Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.
- Change in Systolic Blood Pressure [ Time Frame: Baseline, 1 month ]Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
- Change in Systolic Blood Pressure [ Time Frame: Baseline,4 months ]Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
- Change in Systolic Blood Pressure [ Time Frame: Baseline, end of study (approximately 12 months) ]Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299816
|Contact: Chiazam Omenyi, BSemail@example.com|
|United States, Maryland|
|East Baltimore Medical Campus||Recruiting|
|Baltimore, Maryland, United States, 21202|
|Contact: Chiazam Omenyi, BS 410-614-4137 firstname.lastname@example.org|
|Principal Investigator:||Deidra Crews, MD, ScM||Johns Hopkins University|