Chronic Kidney DiseaseNCT07175896
Dine and DASH Into Wellness Pilot Study
A study testing Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program and Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program in people with Chronic Kidney Disease and Diet Interventions, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and acceptability of a16-week diet coaching program enhanced with cooking classes to improve adherence to the Dietary Approaches to Stop Hypertension (DASH) diet among adults who are at risk for developing chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Diet Interventions, Disease Prevention
- What is being tested?
- Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program and Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 6 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identified Black race
- mild to moderate chronic kidney disease, CKD (eGFR ≥ 60 ml/min/1.73m2 plus albuminuria [Stages 1 or 2] or eGFR 45-59 ml/min/1.73m2 [Stage 3a]) or normal kidney function with at least 1 of the following CKD risk factors:
- Type 2 diabetes or pre-diabetes
- hypertension
- cardiovascular disease (CVD)
- obesity
- age 60 or older
Who cannot join
- eGFR <45 ml/min/1.73m2 (i.e., CKD stages 3b, 4, 5)
- urine dipstick consistent with nephrotic range proteinuria (>3 g)
- receiving dialysis or history of kidney transplant
- Type 1 diabetes
- pregnant, lactating or planning to become pregnant in next 6 months
- lack of internet access and videoconferencing capabilities
Show all 9Show fewer
- planning to relocate in the next 9 months
- unable to read, write and speak in English
- participating in another research study involving diet, exercise or weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research
Durham, North Carolina, 27705
About this study
Official title: Community-based Diet Intervention for Kidney Health in Black Americans
The purpose of this study is to determine the feasibility and acceptability of a16-week diet coaching program enhanced with cooking classes to improve adherence to the Dietary Approaches to Stop Hypertension (DASH) diet among adults who are at risk for developing chronic kidney disease.
Read the detailed description
Excess cardiovascular disease (CVD) mortality among Black Americans with chronic kidney disease (CKD) is a significant US public health disparity. Compared to their White counterparts, Black adults develop kidney disease earlier in life, are 3 times more likely to develop kidney failure necessitating dialysis or kidney transplantation, and are 1.5 times more likely to die prematurely from CVD. Epidemiologic-based studies suggest that greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet improves markers of kidney function and cardiovascular outcomes in Black adults. Yet, adherence to the DASH diet is low among US adults. It is hypothesized that a 16-week culturally-tailored, dietitian-led coaching program enhanced with cooking classes will increase adherence to the DASH diet among Black adults who are at-risk for developing CKD. To inform the design of a future adequately powered clinical trial, investigators will determine the feasibility, acceptability, and preliminary efficacy of delivering a diet coaching program in community-based settings.
In this pilot trial, participants will be recruited from the local community and randomized 1:1 to receive the 16-week diet coaching program as part of an immediate-start intervention group or a delayed-start intervention group consisting of four cohorts of 12 participants. Data collection visits will occur at baseline, 16 weeks and 32 weeks. Study data will include demographic information, healthy histories, psychosocial surveys, 24-hour dietary recalls, physical measurements and laboratory data. Rates of participant recruitment, retention, group attendance and data collection will determine feasibility. Participant satisfaction ratings will determine program acceptability.
- Being tested
- Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program, Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program
- Keywords
- chronic kidney disease, disease prevention, pilot study, diet, DASH, dietary approaches to stop hypertension, diet intervention
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programBehavioural
Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes
Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programBehavioural
Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes
| Study group | Role | What they receive |
|---|---|---|
| Delayed-Start | Placebo comparator | 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. Receives: Behavioral: Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program |
| Immediate-Start | Experimental | 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. Receives: Behavioral: Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DASH (Dietary Approaches to Stop Hypertension) diet score
A DASH diet score assesses adherence to the Dietary Approaches to Stop Hypertension diet, uses a system that gives higher points for more servings of healthy foods (fruits, vegetables, whole grains, low-fat dairy, nuts, seeds, legumes) and lower points for unhealthy foods (red meat, sweetened beverages, sodium, saturated fat). The scores are then summed, with higher overall scores indicating greater adherence to the DASH eating plan.
Measured: Baseline to 16 weeks post-intervention
Secondary outcomes (11)
Total number of study visits completed by participants
Measured: Baseline, 4 months, 8 months
Number of intervention group visits attended by participants
Measured: 4 months
Program satisfaction score
Overall satisfaction score for the diet coaching program. Scored on a Likert scale of 1 (very unsatisfied) to 5 (very satisfied).
Measured: 4 months post-intervention
Change in systolic blood pressure
Change was measured by determining the difference between mean clinic systolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in diastolic blood pressure
Change was measured by determining the difference between mean clinic diastolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in random urine albumin-to-creatinine ration
Change was measured by determining the difference in random urine albumin-to-creatinine ratio obtained at 16 weeks from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in serum creatinine
Change was measured by determining the difference in serum creatinine obtained at 16 weeks from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in total cholesterol
Change was measured by determining the difference in total cholesterol obtained at 16 weeks from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in high-density lipoprotein
Change was measured by determining the difference in high-density lipoprotein obtained at 16 weeks from baseline value.
Measured: Baseline to 16 weeks post-intervention
Change in hemoglobin A1C (glycated hemoglobin)
Change was measured by determining the difference in hemoglobin A1C obtained at 16 weeks from baseline value.
Measured: Baseline to 16 weeks post-intervention
Number of randomized participants
Total number of participants randomized in the study during the 6 month enrollment period.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025
- Primary completion14 May 2026
- Study completion6 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal Tyson, MD, MHS, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175896
- Sponsor's protocol ID
- Pro00118349
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data sets that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Diet Intervention for Kidney Health in Black Americans
- ClinicalTrials.gov ID
- NCT07175896
- Acronym / sponsor ID
- Pro00118349
- Keywords
- chronic kidney disease, disease prevention, pilot study, diet, DASH, dietary approaches to stop hypertension, diet intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 6 Oct 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility and acceptability of a16-week diet coaching program enhanced with cooking classes to improve adherence to the Dietary Approaches to Stop Hypertension (DASH) diet among adults who are at risk for developing chronic kidney disease.
Detailed description
Excess cardiovascular disease (CVD) mortality among Black Americans with chronic kidney disease (CKD) is a significant US public health disparity. Compared to their White counterparts, Black adults develop kidney disease earlier in life, are 3 times more likely to develop kidney failure necessitating dialysis or kidney transplantation, and are 1.5 times more likely to die prematurely from CVD. Epidemiologic-based studies suggest that greater adherence to the Dietary Approaches to Stop Hypertension (DASH) diet improves markers of kidney function and cardiovascular outcomes in Black adults. Yet, adherence to the DASH diet is low among US adults. It is hypothesized that a 16-week culturally-tailored, dietitian-led coaching program enhanced with cooking classes will increase adherence to the DASH diet among Black adults who are at-risk for developing CKD. To inform the design of a future adequately powered clinical trial, investigators will determine the feasibility, acceptability, and preliminary efficacy of delivering a diet coaching program in community-based settings.
In this pilot trial, participants will be recruited from the local community and randomized 1:1 to receive the 16-week diet coaching program as part of an immediate-start intervention group or a delayed-start intervention group consisting of four cohorts of 12 participants. Data collection visits will occur at baseline, 16 weeks and 32 weeks. Study data will include demographic information, healthy histories, psychosocial surveys, 24-hour dietary recalls, physical measurements and laboratory data. Rates of participant recruitment, retention, group attendance and data collection will determine feasibility. Participant satisfaction ratings will determine program acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed-Start | Placebo comparator | Behavioral: Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programAfter 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. |
| Immediate-Start | Experimental | Behavioral: Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identified Black race
- mild to moderate chronic kidney disease, CKD (eGFR ≥ 60 ml/min/1.73m2 plus albuminuria [Stages 1 or 2] or eGFR 45-59 ml/min/1.73m2 [Stage 3a]) or normal kidney function with at least 1 of the following CKD risk factors:
Key exclusion criteria (9 listed)
- eGFR <45 ml/min/1.73m2 (i.e., CKD stages 3b, 4, 5)
- urine dipstick consistent with nephrotic range proteinuria (>3 g)
- receiving dialysis or history of kidney transplant
- Type 1 diabetes
- pregnant, lactating or planning to become pregnant in next 6 months
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 |
|---|---|---|
| Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programLow-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes | Behavioural | Immediate-Start |
| Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking programLow-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes | Behavioural | Delayed-Start |
Primary outcome
Change in DASH (Dietary Approaches to Stop Hypertension) diet score
Time frame: Baseline to 16 weeks post-intervention
A DASH diet score assesses adherence to the Dietary Approaches to Stop Hypertension diet, uses a system that gives higher points for more servings of healthy foods (fruits, vegetables, whole grains, low-fat dairy, nuts, seeds, legumes) and lower points for unhealthy foods (red meat, sweetened beverages, sodium, saturated fat). The scores are then summed, with higher overall scores indicating greater adherence to the DASH eating plan.
11 secondary outcomes
Total number of study visits completed by participants
Time frame: Baseline, 4 months, 8 months
Number of intervention group visits attended by participants
Time frame: 4 months
Program satisfaction score
Time frame: 4 months post-intervention
Change in systolic blood pressure
Time frame: Baseline to 16 weeks post-intervention
Change in diastolic blood pressure
Time frame: Baseline to 16 weeks post-intervention
Change in random urine albumin-to-creatinine ration
Time frame: Baseline to 16 weeks post-intervention
Change in serum creatinine
Time frame: Baseline to 16 weeks post-intervention
Change in total cholesterol
Time frame: Baseline to 16 weeks post-intervention
Change in high-density lipoprotein
Time frame: Baseline to 16 weeks post-intervention
Change in hemoglobin A1C (glycated hemoglobin)
Time frame: Baseline to 16 weeks post-intervention
Number of randomized participants
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. All individual participant data sets that underlie results in a publication
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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.
Crystal Tyson, MD, MHS principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program and Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program in people with Chronic Kidney Disease and Diet Interventions, run by Duke 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 DASH (Dietary Approaches to Stop Hypertension) diet score (time frame: Baseline to 16 weeks post-intervention). 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 28 Aug 2026.