Clinical Trials Directory

Trials / Completed

CompletedNCT03299816

Five, Plus Nuts and Beans for Kidneys

Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
142 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
21 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2018-02-22
Primary completion
2021-11-22
Completion
2021-12-08
First posted
2017-10-03
Last updated
2023-06-22
Results posted
2023-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03299816. Inclusion in this directory is not an endorsement.