Status:
COMPLETED
sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Urolithiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended flui...
Detailed Description
The study uses a randomized controlled trial design with a 12-month intervention period and outcome assessments at baseline, 1, 3, and 12 months. Participants will be randomly assigned to groups. Both...
Eligibility Criteria
Inclusion
- previous diagnosis of symptomatic kidney stone in past 5 yrs
- 24-hr urine volume ≤ 2.0 L/day,
- age 18 or older,
- own iOS or Android smartphone,
- proficient in English language,
- capable of providing informed consent, and
- willing to use a Fitbit smartwatch, connected water bottle, and mobile app for the study every day for a year, and receive text messages reminder to drink.
Exclusion
- previous diagnosis with cystine stone,
- pregnant or planning to become pregnant in the next 12 months,
- concurrently participating in another study involving fluid intake or diet,
- plan to have surgery or relocate outside the area within the next year
- co-morbidities that preclude high fluid intake, conditions with high fluid losses (e.g., congestive heart failure, bariatric surgery, GI tract ostomy, short gut syndrome, chronic diarrhea including patients with ulcerative colitis/Crohn's disease, hyponatremia), or conditions that preclude ability to collect 24-hour urine (severe urinary incontinence),
- active medical treatments that would impair protocol compliance,
- chronic use of lithium, or
- psychiatric conditions impairing compliance with the study protocol.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05196113
Start Date
January 4 2022
End Date
April 28 2025
Last Update
September 16 2025
Active Locations (2)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033