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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Diabetes Mellitus; Albuminuria
• Interventions: Behavioral: Remote counseling

• Registration Number: NCT03015480
• Lead Sponsor: Geisinger Clinic

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)

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-02-13
• Primary Completion: 2018-11-25
• Study Completion: 2018-11-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote counseling	Remote counseling	This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour urine sodium	baseline to 12 months	unadjusted and adjusted for creatinine excretion

Secondary Outcome Measures

Name	Time	Method
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 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	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 24-hour Urine Albumin Excretion	baseline to 12 months	unadjusted and adjusted for creatinine excretion

Trial Locations

Locations (2)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States