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

NCT ID: NCT03015480

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2018-11-25

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)

Conditions

Chronic Kidney Disease; Diabetes Mellitus; Albuminuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Remote counseling

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

Group Type: EXPERIMENTAL

Remote counseling

Intervention Type: BEHAVIORAL

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.

Interventions

Remote 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Countries

United States

References

Schrauben SJ, Inamdar A, Yule C, Kwiecien S, Krekel C, Collins C, Anderson C, Bailey-Davis L, Chang AR. Effects of Dietary App-Supported Tele-Counseling on Sodium Intake, Diet Quality, and Blood Pressure in Patients With Diabetes and Kidney Disease. J Ren Nutr. 2022 Jan;32(1):39-50. doi: 10.1053/j.jrn.2021.08.006. Epub 2021 Oct 11.

Reference Type: DERIVED

PMID: 34649784 (View on PubMed)

Other Identifiers

2016-0382

Identifier Type: -

Identifier Source: org_study_id