Trials / Active Not Recruiting
Active Not RecruitingNCT07175896
Dine and DASH Into Wellness Pilot Study
Community-based Diet Intervention for Kidney Health in Black Americans
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program | Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes |
| BEHAVIORAL | Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program | Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2026-06-02
- Completion
- 2026-10-06
- First posted
- 2025-09-16
- Last updated
- 2026-01-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07175896. Inclusion in this directory is not an endorsement.