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Active, Not Recruiting

NCT Number: NCT07175896

Dine and DASH Into Wellness Pilot Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Kidney Disease Chronic Disease Diet Interventions Disease Attributes Disease Prevention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Clinical Research

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program

Behavioral

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 program

Behavioral

Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes

Primary outcomes

  1. Number of randomized participants

    Time frame: Up to 6 months

    Total number of participants randomized in the study during the 6 month enrollment period.

Secondary outcomes

  1. Total number of study visits completed by participants

    Time frame: Baseline, 4 months, 8 months

  2. Number of intervention group visits attended by participants

    Time frame: 4 months

  3. Program satisfaction score

    Time frame: 4 months post-intervention

    Overall satisfaction score for the diet coaching program. Scored on a Likert scale of 1 (very unsatisfied) to 5 (very satisfied).

  4. 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.

  5. Change in systolic blood pressure

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference between mean clinic systolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.

  6. Change in diastolic blood pressure

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference between mean clinic diastolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.

  7. Change in random urine albumin-to-creatinine ration

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference in random urine albumin-to-creatinine ratio obtained at 16 weeks from baseline value.

  8. Change in serum creatinine

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference in serum creatinine obtained at 16 weeks from baseline value.

  9. Change in total cholesterol

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference in total cholesterol obtained at 16 weeks from baseline value.

  10. Change in high-density lipoprotein

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference in high-density lipoprotein obtained at 16 weeks from baseline value.

  11. Change in hemoglobin A1C (glycated hemoglobin)

    Time frame: Baseline to 16 weeks post-intervention

    Change was measured by determining the difference in hemoglobin A1C obtained at 16 weeks from baseline value.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Community-based Diet Intervention for Kidney Health in Black Americans

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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