Albuminuria, Chronic Kidney Disease, Diabetes Mellitus
Conditions
Keywords
Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Albuminuria, Diet
Brief summary
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
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)
Interventions
BEHAVIORALRemote counseling
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.
Sponsors
Johns Hopkins University
Geisinger Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour urine sodium | baseline to 12 months | unadjusted and adjusted for creatinine excretion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine sodium/potassium ratio | baseline to 12 months | — |
| Change in Healthy Eating Index (HEI) score | baseline to 12 months | Assessed by three 24-hour dietary recalls obtained by phone at each time point |
| Change in 24-hour Urine Albumin Excretion | baseline to 12 months | unadjusted and adjusted for creatinine excretion |
| Change in 24-hour Ambulatory Systolic Blood Pressure | baseline to 12 months | — |
| Change in 24-hour urine phosphorus | baseline to 12 months | unadjusted and adjusted for creatinine excretion |
| Change in Net Endogenous Acid Production (NEAP) | baseline to 12 months | NEAP (mEq/d) = -10.2 + 54.5 (protein \[g/d\]/potassium \[mEq/d\]) |
| Change in weight | baseline to 12 months | — |
Countries
United States
Outcome results
None listed