DASH Diet Program for Chronic Kidney Disease Prevention

Overseen By Jeanette Rutledge, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: CKD stages 3b-5, Type 1 diabetes, Pregnancy, others

Compensation: Varies

Number of Visits: 18

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 16-week diet coaching program, enhanced with cooking classes, to help individuals adhere to the DASH diet. The goal is to determine if this approach can prevent chronic kidney disease, particularly in those with risk factors such as high blood pressure, diabetes, or obesity. Participants will either begin the program immediately or wait 16 weeks before starting. The trial seeks Black adults with mild to moderate kidney issues or risk factors like type 2 diabetes or high blood pressure. As an unphased trial, it offers participants the chance to contribute to significant research that could improve health outcomes for those at risk of chronic kidney disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the DASH Diet Coaching Program is safe?

Research has shown that the DASH diet, when followed properly, can be safely included in daily routines. It is linked to better kidney health and a lower risk of severe kidney disease, particularly for individuals with ongoing kidney issues and high blood pressure. Studies have found that the diet can help reduce blood pressure and improve heart health.

The program guiding people in following the DASH diet is also safe. It includes online sessions with a dietitian and cooking classes to facilitate healthy eating. This method has been well-received and has not shown any major safety concerns in studies. Participants often report improved eating habits and a clearer understanding of nutrition labels and portion sizes.

Overall, both the DASH diet and the coaching program are considered safe and well-accepted by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DASH Diet Coaching Program for chronic kidney disease prevention because it takes a proactive and personalized approach to dietary management. Unlike traditional treatments that might focus on medication, this program emphasizes learning and lifestyle changes tailored to individual cultural food preferences. Participants receive hands-on cooking classes and personalized coaching from a registered dietitian, helping them adopt a low-sodium DASH diet that’s both sustainable and effective. This method not only aims to prevent the progression of kidney disease but also empowers individuals to take control of their health through practical, everyday changes.

What evidence suggests that the DASH Diet Coaching Program is effective for preventing chronic kidney disease?

Studies have shown that the DASH diet, which stands for Dietary Approaches to Stop Hypertension, can improve kidney function and lower the risk of developing chronic kidney disease (CKD). Research suggests that following this diet links to better blood pressure, crucial for maintaining kidney health. One study found that people on the DASH diet consumed more fruits and vegetables, which benefit the kidneys. The diet also connects to a slower decline in kidney function over time. In this trial, participants in the Immediate-Start arm will receive coaching to follow the DASH diet, which appears promising for those at risk of kidney disease. Meanwhile, the Delayed-Start group will initially be observed without intervention before receiving the same program. ^{1 2 3 6 7}

Who Is on the Research Team?

Crystal Tyson, MD, MHS

Principal Investigator

Duke

Are You a Good Fit for This Trial?

This trial is for adults at risk of chronic kidney disease, specifically those with cardiovascular disease, obesity, Type 2 diabetes or pre-diabetes, hypertension, self-identified Black race and aged 60 or older. It aims to help them improve their diet.

Inclusion Criteria

I have type 2 diabetes or pre-diabetes.

I have high blood pressure.

I have a heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation (Delayed-Start Group)

Delayed-Start group is observed for 16 weeks with no study activity

16 weeks

1 visit (baseline)

Diet Coaching Program (Immediate-Start Group)

Immediate-Start group receives a 16-week diet coaching program with virtual sessions and cooking classes

16 weeks

16 weekly virtual sessions

Follow-up

Participants follow the DASH diet on their own for an additional 16 weeks

16 weeks

1 visit (32 weeks)

What Are the Treatments Tested in This Trial?

Interventions

• DASH Diet Coaching Program

Trial Overview The study tests a 16-week program where participants receive group coaching on the low-sodium DASH diet along with cooking classes. Some start immediately while others are delayed in starting the program to compare outcomes.

How Is the Trial Designed?

Group I: Immediate-Start Experimental Treatment 1 Intervention

Each participant in the Immediate-Start arm will receive one 30-minute individual virtual session with the dietitian and advised to follow a low-sodium diet followed by 16 weekly group Kidney Health Nutrition and Cooking sessions. Didactic group sessions will occur virtually. During the ten virtual sessions, participants will be coached by a registered dietitian to follow a low-sodium DASH diet, taught to read food labels, and balance food portions. The six cooking classes will consist of hands-on instruction aimed to enhance cooking skills and help participants create nutrient-rich meals that are consistent with DASH diet principles using food staples that are common to participants' culture. Following the intervention, they will follow the DASH diet on their own for an additional 16 weeks.

Group II: Delayed-Start Placebo Group 1 Intervention

After randomization, the Delayed-Start group will be observed for 16 weeks with no study activity. Following the observation period, they will complete a 16-week study visit and then receive the same Kidney Health Nutrition and Cooking program that was delivered to the Immediate-Start group.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07175896

NCT07175896 | Dine and DASH Into Wellness Pilot Study Epidemiologic-based studies suggest that greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet improves markers of kidney function and ...

2. ajmc.com ajmc.com/view/ckd-outcomes-improve-for-black-adults-when-dash-diet-is-combined-with-coaching-assistance

CKD Outcomes Improve for Black Adults When DASH Diet ... The C-DASH group had statistically significant greater increases in potassium and fruit and vegetable consumption than the group that did not ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10344422/

Self-Perceived Barriers and Facilitators to DASH Diet ... The Dietary Approaches to Stop Hypertension eating plan (DASH) improves hypertension and is associated with favorable CKD and cardiovascular disease outcomes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531718313745

Adherence to the dietary approaches to stop hypertension ... Based on their results, the DASH diet was inversely associated with the incidence of CKD and protective against a rapid decline in eGFR [45].

5. ajkd.org ajkd.org/article/S0272-6386(16)30257-8/abstract

DASH (Dietary Approaches to Stop Hypertension) Diet and ... Conclusions. Consuming a DASH-style diet was associated with lower risk for kidney disease independent of demographic characteristics, established kidney risk ...

6. kidney-international.org kidney-international.org/article/S0085-2538(19)30168-1/fulltext

The Dietary Approaches to Stop Hypertension (DASH) diet ... The DASH diet is associated with lower risk of end-stage kidney disease in individuals with stage 3 chronic kidney disease and hypertension.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7057309/

A Coaching Program to Improve Dietary Intake of Patients ... Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in ...