Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes

Conditions
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Chronic Kidney Disease, Diabetes Mellitus, Albuminuria

Intervention / Treatment
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* Behavioral: Remote counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote counseling<br>This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian. | Behavioral: Remote counseling<br>* For an 8 week period, patients will be asked to enter dietary information into the MyFitnessPal mobile application or website. Dietitians will access this information and provide personalized motivational interview phone calls on a weekly basis. After the initial 8 weeks, patients will receive a dietitian follow-up phone call around 5 and 11 months later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour urine sodium | unadjusted and adjusted for creatinine excretion | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Ambulatory Systolic Blood Pressure |  | baseline to 12 months | 
| Change in urine sodium/potassium ratio |  | baseline to 12 months | 
| Change in Healthy Eating Index (HEI) score | Assessed by three 24-hour dietary recalls obtained by phone at each time point | baseline to 12 months | 
| Change in 24-hour Urine Albumin Excretion | unadjusted and adjusted for creatinine excretion | baseline to 12 months | 
| Change in weight |  | baseline to 12 months | 
| Change in 24-hour urine phosphorus | unadjusted and adjusted for creatinine excretion | baseline to 12 months | 
| Change in Net Endogenous Acid Production (NEAP) | NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d]) | baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albuminuria, Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Diet