Community-based Diet Intervention for Kidney Health in Black Americans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in DASH (Dietary Approaches to Stop Hypertension) diet score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •age 60 or older
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Delayed delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program (Behavioral)
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.
干预措施: Immediate delivery of low-sodium DASH (Dietary Approaches to Stop Hypertension) diet group coaching plus hand-on cooking program (Behavioral)
结局指标
主要结局
Change in DASH (Dietary Approaches to Stop Hypertension) diet score
时间窗: 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.
Number of randomized participants
时间窗: Up to 6 months
Total number of participants randomized in the study during the 6 month enrollment period.
次要结局
- 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)
- Change in diastolic blood pressure(Baseline to 16 weeks post-intervention)
- Change in random urine albumin-to-creatinine ration(Baseline to 16 weeks post-intervention)
- Change in serum creatinine(Baseline to 16 weeks post-intervention)
- Change in total cholesterol(Baseline to 16 weeks post-intervention)
- Change in high-density lipoprotein(Baseline to 16 weeks post-intervention)
- Number of randomized participants(Up to 6 months)
- Change in high-density lipoprotein(Baseline to 16 weeks post-intervention)
- Change in random urine albumin-to-creatinine ration(Baseline to 16 weeks post-intervention)
- Change in serum creatinine(Baseline to 16 weeks post-intervention)
- Change in total cholesterol(Baseline to 16 weeks post-intervention)
- 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)
- Change in diastolic blood pressure(Baseline to 16 weeks post-intervention)
- Change in hemoglobin A1C (glycated hemoglobin)(Baseline to 16 weeks post-intervention)