Chronic Kidney Disease, Diet Interventions, Disease Prevention
Conditions
Keywords
chronic kidney disease, disease prevention, pilot study, diet, DASH, dietary approaches to stop hypertension, diet intervention
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.
Interventions
BEHAVIORALImmediate 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
BEHAVIORALDelayed 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
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DASH (Dietary Approaches to Stop Hypertension) diet score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Overall satisfaction score for the diet coaching program. Scored on a Likert scale of 1 (very unsatisfied) to 5 (very satisfied). |
| Change in systolic blood pressure | 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. |
| Change in diastolic blood pressure | 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. |
| Change in random urine albumin-to-creatinine ration | 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. |
| Change in serum creatinine | Baseline to 16 weeks post-intervention | Change was measured by determining the difference in serum creatinine obtained at 16 weeks from baseline value. |
| Change in total cholesterol | Baseline to 16 weeks post-intervention | Change was measured by determining the difference in total cholesterol obtained at 16 weeks from baseline value. |
| Change in high-density lipoprotein | Baseline 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 hemoglobin A1C (glycated hemoglobin) | Baseline to 16 weeks post-intervention | Change was measured by determining the difference in hemoglobin A1C obtained at 16 weeks from baseline value. |
| Number of randomized participants | Up to 6 months | Total number of participants randomized in the study during the 6 month enrollment period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCrystal Tyson, MD, MHS
Duke
Outcome results
None listed