sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
- Conditions
- Urolithiasis
- Interventions
- Behavioral: sipIT
- Registration Number
- NCT05196113
- Lead Sponsor
- Penn State University
- 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 fluid consumption guidelines in participants with a history of urolithiasis.
- 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 groups will receive usual care which involves education about fluid intake guidelines and encouragement to adhere to those guidelines from a clinician. The intervention group will additionally receive the sipIT intervention comprising a semi-automated fluid intake tracking system and context-sensitive, just-in-time notifications reminding them to drink.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sipIT sipIT Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake.
- Primary Outcome Measures
Name Time Method 24-hr urine volume 3 months Change in urine volume from baseline
- Secondary Outcome Measures
Name Time Method 24-hr urine volume 1 month and 12 months Change in urine volume from baseline
Urine supersaturations 1 month, 3 months, and 12 months Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months
Habit strength for fluid intake 3 months, and 12 months Change in habit by the 4-item Self-Report Behavioural Automaticity Index (Gardner, Abraham, Lally \& de Bruijn, 2012, Int J Beh Nutr Phys Act; baseline to 3/12 months). Responses will be averaged so scores range from 1 (strongly disagree) to 7 (strongly agree) with higher scores indicating stronger habits for fluid intake.
Past-week fluid intake 3 months, and 12 months Change in past-week volume of fluid intake from baseline to 3/12 months
Trial Locations
- Locations (2)
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Pennsylvania State University
🇺🇸University Park, Pennsylvania, United States