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Completed

NCT Number: NCT05196113

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 24-hr urine volume

    Time frame: 12 months

    Change in urine volume from baseline

Secondary outcomes

  1. 24-hr urine volume

    Time frame: 1 month and 3 months

    Change in urine volume from baseline

  2. Urine supersaturations

    Time frame: 1 month, 3 months, and 12 months

    Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months

  3. Habit strength for fluid intake

    Time frame: 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.

  4. Past-week fluid intake

    Time frame: 3 months, and 12 months

    Change in past-week volume of fluid intake from baseline to 3/12 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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