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Completed

NCT Number: NCT03015480

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

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.

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Key information

Conditions

Chronic Kidney Disease Albuminuria Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center, Danville, Pennsylvania, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Remote counseling

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.

Primary outcomes

  1. Change in 24-hour urine sodium

    Time frame: baseline to 12 months

    unadjusted and adjusted for creatinine excretion

Secondary outcomes

  1. Change in 24-hour Ambulatory Systolic Blood Pressure

    Time frame: baseline to 12 months

  2. Change in urine sodium/potassium ratio

    Time frame: baseline to 12 months

  3. Change in Healthy Eating Index (HEI) score

    Time frame: baseline to 12 months

    Assessed by three 24-hour dietary recalls obtained by phone at each time point

  4. Change in 24-hour Urine Albumin Excretion

    Time frame: baseline to 12 months

    unadjusted and adjusted for creatinine excretion

  5. Change in weight

    Time frame: baseline to 12 months

  6. Change in 24-hour urine phosphorus

    Time frame: baseline to 12 months

    unadjusted and adjusted for creatinine excretion

  7. Change in Net Endogenous Acid Production (NEAP)

    Time frame: baseline to 12 months

    NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Johns Hopkins University

Registry information

Acronym: FitKidney

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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