Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in 24-hour urine sodium
研究概览
简要总结
This pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
详细描述
Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using MyFitnessPal on their smartphone or computer to log meal data daily, weekly website educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients receive a follow-up phone call from the dietitian and 5 and 11 months for further support and counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot study examines the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
Main outcomes include sodium intake assessed by 24 hour urine collection as well as other dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index score, 24-hour urine phosphorus, estimated net endogenous acid production) and health measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years
- •Diabetes diagnosis (Type I or Type II)
- •Last urine albumin/creatinine ratio (ACR) within the past two years > 30 mg/g
- •Last outpatient estimated glomerular filtration rate (eGFR) within the past year > 45 ml/min/1.73m2
- •Last outpatient systolic blood pressure (SBP) within the past year < 160 mmHg
- •Last outpatient diastolic blood pressure (DBP) within the past year <100 mmHg
- •Preceding eGFR decline rate less than -2 ml/min/1.73m2/y
- •At least 2 outpatient eGFR measurements in electronic health record, separated by at least 2 years
- •Agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake)
- •Access to smartphone or computer
排除标准
- •Inability to understand English
- •Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months.
- •Current treatment for malignancy
- •Planned bariatric surgery
- •Pregnancy or planning to become pregnant within next 2 years
- •Self-reported average consumption of > 14 alcoholic beverages per week
- •Psychiatric hospitalization in past year
- •Unstable angina
- •Urine ACR > 2500 mg/g
- •Last potassium > 5.0 mg/dL
- •Hypoglycemia episode in past 1 month (glucose < 70 mg/dL)
- •Principal investigator discretion (i.e. concerns about safety, compliance)
研究组 & 干预措施
Remote counseling
This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.
干预措施: Remote counseling (Behavioral)
结局指标
主要结局
Change in 24-hour urine sodium
时间窗: baseline to 12 months
unadjusted and adjusted for creatinine excretion
次要结局
- Change in urine sodium/potassium ratio(baseline to 12 months)
- Change in Healthy Eating Index (HEI) score(baseline to 12 months)
- Change in weight(baseline to 12 months)
- Change in 24-hour Ambulatory Systolic Blood Pressure(baseline to 12 months)
- Change in 24-hour urine phosphorus(baseline to 12 months)
- Change in Net Endogenous Acid Production (NEAP)(baseline to 12 months)
- Change in 24-hour Urine Albumin Excretion(baseline to 12 months)