NCT03015480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 4, 2017

Last Update Submit

February 27, 2019

Conditions

Chronic Kidney DiseaseDiabetes MellitusAlbuminuria

Keywords

Mobile ApplicationChronic Kidney DiseaseDiabetes MellitusAlbuminuriaDiet

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour urine sodium

    unadjusted and adjusted for creatinine excretion

    baseline to 12 months

Secondary Outcomes (7)

  • Change in 24-hour Ambulatory Systolic Blood Pressure

    baseline to 12 months

  • Change in urine sodium/potassium ratio

    baseline to 12 months

  • Change in Healthy Eating Index (HEI) score

    baseline to 12 months

  • Change in 24-hour Urine Albumin Excretion

    baseline to 12 months

  • Change in weight

    baseline to 12 months

  • +2 more secondary outcomes

Study Arms (1)

Remote counseling

EXPERIMENTAL

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

Behavioral: Remote counseling

Interventions

Remote counselingBEHAVIORAL

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.

Remote counseling

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (1)

  • 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.

    PMID: 34649784DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusAlbuminuria

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and Symptoms

Study Officials

  • Alex Chang, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 10, 2017

Study Start

February 13, 2017

Primary Completion

November 25, 2018

Study Completion

November 25, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)