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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Behavioral: sipIT

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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sipIT; 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; 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.
No Intervention: Control; Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: David E Conroy, PhD, The Pennsylvania State University; Principal Investigator: Necole M Streeper, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): August 29, 2025

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Calculi; Nephrolithiasis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis; Kidney Calculi
• Other Study ID Numbers: STUDY00015540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No