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

Geisinger Health

Status: Completed

Conditions: Chronic Kidney Disease; Diabetes Mellitus; Albuminuria

Treatments: Behavioral: Remote counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03015480

2016-0382

Details and patient eligibility

About

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.

Full 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)

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Remote counseling

Experimental group

Description:

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

Treatment:

Behavioral: Remote counseling