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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of randomized participants | Total number of participants randomized in the study during the 6 month enrollment period. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of study visits completed by participants | Baseline, 4 months, 8 months | |
| Number of intervention group visits attended by participants | 4 months | |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crystal Tyson, MD, MHS | Duke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research | Durham | North Carolina | 27705 | United States |
All individual participant data sets that underlie results in a publication
Data will be available within 6 months of outcome publication
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
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| 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 |
|
| Program satisfaction score |
Overall satisfaction score for the diet coaching program. Scored on a Likert scale of 1 (very unsatisfied) to 5 (very satisfied). |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline to 16 weeks post-intervention |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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