Chronic Kidney DiseaseFitKidneyNCT03015480
Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
A study testing Remote counseling in people with Chronic Kidney Disease and Diabetes Mellitus, run by Geisinger Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease, Diabetes Mellitus, Albuminuria
- What is being tested?
- Remote counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2017to 25 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
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.
Read the 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
- Being tested
- Remote counseling
- Keywords
- Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Albuminuria, Diet
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote counseling | Experimental | This group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian. Receives: Behavioral: Remote counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour urine sodium
unadjusted and adjusted for creatinine excretion
Measured: baseline to 12 months
Secondary outcomes (7)
Change in 24-hour Ambulatory Systolic Blood Pressure
Measured: baseline to 12 months
Change in urine sodium/potassium ratio
Measured: baseline to 12 months
Change in Healthy Eating Index (HEI) score
Assessed by three 24-hour dietary recalls obtained by phone at each time point
Measured: baseline to 12 months
Change in 24-hour Urine Albumin Excretion
unadjusted and adjusted for creatinine excretion
Measured: baseline to 12 months
Change in weight
Measured: baseline to 12 months
Change in 24-hour urine phosphorus
unadjusted and adjusted for creatinine excretion
Measured: baseline to 12 months
Change in Net Endogenous Acid Production (NEAP)
NEAP (mEq/d) = -10.2 + 54.5 (protein [g/d]/potassium [mEq/d])
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start13 Feb 2017
- Primary completion25 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Alex Chang, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015480
- Sponsor's protocol ID
- 2016-0382
- Acronym
- FitKidney
- Status last verified
- Feb 2019
- First submitted
- 4 Jan 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34649784
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03015480
- Acronym / sponsor ID
- FitKidney / 2016-0382
- Conditions
- Chronic Kidney Disease, Diabetes Mellitus, Albuminuria
- Keywords
- Mobile Application, Chronic Kidney Disease, Diabetes Mellitus, Albuminuria, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote counseling | Experimental | Behavioral: Remote counselingThis group of people will be asked to track dietary information on MyFitnessPal and receive remote dietary counseling with a dietitian. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote counselingFor 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. | Behavioural | Remote counseling |
Primary outcome
Change in 24-hour urine sodium
Time frame: baseline to 12 months
unadjusted and adjusted for creatinine excretion
7 secondary outcomes
Change in 24-hour Ambulatory Systolic Blood Pressure
Time frame: baseline to 12 months
Change in urine sodium/potassium ratio
Time frame: baseline to 12 months
Change in Healthy Eating Index (HEI) score
Time frame: baseline to 12 months
Change in 24-hour Urine Albumin Excretion
Time frame: baseline to 12 months
Change in weight
Time frame: baseline to 12 months
Change in 24-hour urine phosphorus
Time frame: baseline to 12 months
Change in Net Endogenous Acid Production (NEAP)
Time frame: baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 34649784Schrauben 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Chang, MD principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote counseling in people with Chronic Kidney Disease and Diabetes Mellitus, run by Geisinger Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour urine sodium (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.