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

NCT05196113 | Completed

• 2 other identifiers: STUDY00015540R01DK124469
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 24-hr urine volume

  Change in urine volume from baseline

  12 months

Secondary Outcomes (4)

• 24-hr urine volume

  1 month and 3 months

• Urine supersaturations

  1 month, 3 months, and 12 months

• Habit strength for fluid intake

  3 months, and 12 months

• Past-week fluid intake

  3 months, and 12 months

Study Arms (2)

sipIT

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).

Interventions

sipIT BEHAVIORAL

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.

sipIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previous diagnosis of symptomatic kidney stone in past 5 yrs
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related 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.

  PMID: 38253254 BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David E Conroy, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Necole M Streeper, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 19, 2022
• Study Start: January 4, 2022
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)