sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention

Conditions
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Urolithiasis

Intervention / Treatment
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* Behavioral: sipIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 wear a Fitbit smartwatch daily for 1 year. Exclusion Criteria: 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 (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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sipIT<br>Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake. | Behavioral: sipIT<br>* Intervention has two components: (a) education about fluid intake guidelines and encouragement them to adhere to those guidelines (i.e., drink enough to produce >2.5 L of urine daily), and (b) just-in-time adaptive intervention using a semi-automated tracking system to detect drinking and, following lapses, trigger reminder messages<br>|
| No Intervention: Control<br>Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hr urine volume | Change in urine volume from baseline | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hr urine volume | Change in urine volume from baseline | 1 month and 12 months | 
| Urine supersaturations | Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months | 1 month, 3 months, and 12 months | 
| Habit strength for fluid intake | 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. | 3 months, and 12 months | 
| Past-week fluid intake | Change in past-week volume of fluid intake from baseline to 3/12 months | 3 months, and 12 months |