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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes
Low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching enhanced by cooking classes
Duke Clinical Research
Durham, North Carolina, United States
Number of randomized participants
Total number of participants randomized in the study during the 6 month enrollment period.
Time frame: Up to 6 months
Total number of study visits completed by participants
Time frame: Baseline, 4 months, 8 months
Number of intervention group visits attended by participants
Time frame: 4 months
Program satisfaction score
Overall satisfaction score for the diet coaching program. Scored on a Likert scale of 1 (very unsatisfied) to 5 (very satisfied).
Time frame: 4 months post-intervention
Change in DASH (Dietary Approaches to Stop Hypertension) diet score
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.
Time frame: Baseline to 16 weeks post-intervention
Change in systolic blood pressure
Change was measured by determining the difference between mean clinic systolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.
Time frame: Baseline to 16 weeks post-intervention
Change in diastolic blood pressure
Change was measured by determining the difference between mean clinic diastolic blood pressure (mmHg) obtained at 16 weeks (end of treatment) from baseline value.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 16 weeks post-intervention
Change in random urine albumin-to-creatinine ration
Change was measured by determining the difference in random urine albumin-to-creatinine ratio obtained at 16 weeks from baseline value.
Time frame: Baseline to 16 weeks post-intervention
Change in serum creatinine
Change was measured by determining the difference in serum creatinine obtained at 16 weeks from baseline value.
Time frame: Baseline to 16 weeks post-intervention
Change in total cholesterol
Change was measured by determining the difference in total cholesterol obtained at 16 weeks from baseline value.
Time frame: Baseline to 16 weeks post-intervention
Change in high-density lipoprotein
Change was measured by determining the difference in high-density lipoprotein obtained at 16 weeks from baseline value.
Time frame: Baseline to 16 weeks post-intervention
Change in hemoglobin A1C (glycated hemoglobin)
Change was measured by determining the difference in hemoglobin A1C obtained at 16 weeks from baseline value.
Time frame: Baseline to 16 weeks post-intervention