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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05196113
• Other study ID #: STUDY00015540
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: June 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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 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 (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.

Related Conditions & MeSH terms

• Kidney Calculi
• Urolithiasis

Intervention

Behavioral:
• sipIT
Participants receive education and digital tools to monitor their fluid intake and just-in-time text messages to remind them when they have lapsed in regular fluid intake.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Conroy DE, Marks J, Cutshaw A, Ram N, Thomaz E, Streeper NM. Promoting fluid intake to increase urine volume for kidney stone prevention: Protocol for a randomized controlled efficacy trial of the sipIT intervention. Contemp Clin Trials. 2024 Mar;138:107454. doi: 10.1016/j.cct.2024.107454. Epub 2024 Jan 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hr urine volume	Change in urine volume from baseline	3 months
Secondary	24-hr urine volume	Change in urine volume from baseline	1 month and 12 months
Secondary	Urine supersaturations	Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months	1 month, 3 months, and 12 months
Secondary	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
Secondary	Past-week fluid intake	Change in past-week volume of fluid intake from baseline to 3/12 months	3 months, and 12 months