Your session is about to expire
← Back to Search
Behavioral Intervention
DASH Diet for Chronic Kidney Disease
N/A
Waitlist Available
Led By Crystal Tyson, M.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will study whether a behavioral diet intervention can help Black Americans with moderate CKD stick to the DASH diet, which may improve their blood pressure and other CKD-related outcomes.
Who is the study for?
This trial is for Black Americans over 21 with moderate chronic kidney disease (CKD), specifically an eGFR of 30-59 ml/min/1.73m2. It's not for those who've had a kidney transplant, are pregnant or breastfeeding, have severe blood pressure issues, don't speak English, or have high risk of hyperkalemia like uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests how well African Americans with CKD can follow the DASH diet and its effects on their health. Participants will receive counseling to help them adhere to this diet pattern in hopes of improving blood pressure and CKD outcomes.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include discomfort adjusting to new eating habits but no typical drug-related side effects are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24 hour urine concentrations of phosphorus during treatment
Change in 24 hour urine concentrations of potassium during treatment
Change in 24 hour urine concentrations of sodium during treatment
+5 moreSecondary outcome measures
Change in 24-hour mean systolic blood pressure 3-months post-treatment.
Change in body weight 3 months after intervention
Change in body weight during treatment
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Participants will meet one-on-one with the study dietitian for a single 30- minute encounter and be advised to limit daily sodium intake per current clinical practice guidelines for hypertension in patients with CKD. Educational handouts and tip sheets about practical strategies to reduce dietary sodium will be distributed.
Group II: Behavioral Diet CounselingExperimental Treatment1 Intervention
Groups of 4-6 participants will attend 12 weekly dietitian-led counseling sessions and receive coaching on practical strategies to enhance DASH diet adherence and reduce daily sodium intake.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DASH diet counseling
2012
N/A
~50
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,375 Previous Clinical Trials
3,426,892 Total Patients Enrolled
Crystal Tyson, M.D.Principal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high risk for low or very high blood pressure.You have had a kidney transplant in the past.You are at least 21 years old.You have moderate to severe kidney disease, which means your kidneys are not working as well as they should.You have certain health conditions like poorly controlled diabetes or high potassium levels in your blood.You have had high blood pressure in the last 6 months, defined as having a high level of potassium in your blood.People who identify as Black.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Diet Counseling
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial accepting new participants at this time?
"Per the information provided by clinicaltrials.gov, this medical study is actively seeking participants since it was first published on April 14th 2022 and last edited on June 14th of the same year."
Answered by AI
What are the principal aims of this experimental endeavor?
"The primary outcome of this clinical trial, evaluated from the start to 12 weeks, is the number of participants who complete the intervention program. Secondary objectives include a comparison in clinic systolic blood pressure at baseline and end-of-treatment (12wks), body weight comparisons also taken at these two points as well as 3 months post treatment."
Answered by AI
What is the aggregate of individuals partaking in this study?
"Accurately, the data hosted on clinicaltrials.gov confirms that this medical study is actively accepting participants. This trial was first launched on April 14th 2022 and has been recently updated as of June 14th 2022. Currently, 50 individuals are needed to be recruited from a single site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger