Dine and DASH Into Wellness Pilot Study

NCT07175896 | Active Not Recruiting

• 1 other identifier: Pro00118349
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Diet Interventions; Disease Prevention

Keywords

chronic kidney disease; disease prevention; pilot study; diet; DASH; dietary approaches to stop hypertension; diet intervention

Outcome Measures

Primary Outcomes (1)

• Number of randomized participants

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

  Up to 6 months

Secondary Outcomes (11)

• Total number of study visits completed by participants

  Baseline, 4 months, 8 months

• Number of intervention group visits attended by participants

  4 months

• Program satisfaction score

  4 months post-intervention

• Change in DASH (Dietary Approaches to Stop Hypertension) diet score

  Baseline to 16 weeks post-intervention

• Change in systolic blood pressure

  Baseline to 16 weeks post-intervention

Study Arms (2)

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.

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.

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

Interventions

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

Immediate-Start

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

Delayed-Start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Clinical Research

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Crystal Tyson, MD, MHS

  Duke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of outcome publication
• Access Criteria: Qualified researchers with a sound proposal may request de-identified IPD underlying the published results. Requests should include a brief research plan/analysis plan, ethics/IRB approval or exemption, and data security procedures. Approved requesters must sign a Data Use Agreement (no re-identification, no re-distribution, analysis limited to the approved purpose, secure storage, destroy/return data at project end). Submit requests to the study PI at cs206@dm.duke.edu

Locations

US (1)