Dine and DASH Into Wellness Pilot Study

NCT ID: NCT07175896

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-10-06

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.

Conditions

Chronic Kidney Disease; Diet Interventions; Disease Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delayed-Start

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Immediate-Start

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 Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal Tyson, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke

Locations

Duke Clinical Research

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00118349

Identifier Type: -

Identifier Source: org_study_id