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Dine and DASH Into Wellness Pilot Study

Not Applicable
Not yet recruiting
Conditions
Diet Interventions
Chronic Kidney Disease
Disease Prevention
Registration Number
NCT07175896
Lead Sponsor
Duke University
Brief 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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
48
Inclusion Criteria
  • self-identified Black race

  • mild to moderate 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
    • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Number of randomized participantsUp to 6 months

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

Secondary Outcome Measures
NameTimeMethod
Total number of study visits completed by participantsBaseline, 4 months, 8 months
Change in high-density lipoproteinBaseline to 16 weeks post-intervention

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

Change in systolic blood pressureBaseline 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.

Change in random urine albumin-to-creatinine rationBaseline 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.

Number of intervention group visits attended by participants4 months
Program satisfaction score4 months post-intervention

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

Change in DASH (Dietary Approaches to Stop Hypertension) diet scoreBaseline 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.

Change in diastolic blood pressureBaseline 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.

Change in total cholesterolBaseline to 16 weeks post-intervention

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

Change in serum creatinineBaseline to 16 weeks post-intervention

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

Change in hemoglobin A1CBaseline to 16 weeks post-intervention

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

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