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OpenTrials
Completed

NCT Number: NCT06269783

Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

The study is a six-month ecological momentary assessment study of patients using the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors that disrupt routines during the 3-month intervention period, and monthly assessments of motivation and life events or stressors that disrupt routines in the three months following the end of intervention (months 4-6). The mini-sipIT intervention includes automated and manual tracking of fluid intake and lapse-contingent reminders to drink.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previous diagnosis of symptomatic kidney stone in the past 5 years,
  • Age 18 or older,
  • Own an iOS or Android smart phone,
  • Proficient in English,
  • Capable of providing informed consent,
  • Willing to use the water bottle and companion app & receive text message reminders for 3 months,
  • Live in continental US.

Exclusion criteria

  • Pregnant or planning to become pregnant during the next 6 months,
  • Concurrently participating in other study involving fluid intake or diet,
  • Plan to have surgery in the next 6 months,
  • Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or
  • Active medical treatments that would impair protocol compliance.

Treatment and study plan

sipIT

Behavioral

Automated and manual fluid tracking system with just-in-time reminder messages to support fluid intake habit formation.

Primary outcomes

  1. Urine volume (intervention)

    Time frame: from baseline to the end of the intervention period (3 months)

    Change in urine volume

Secondary outcomes

  1. Urine volume (maintenance)

    Time frame: from the end of the intervention period (3 months) to the maintenance change at 6 months

    Change in urine volume

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
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
May 26, 2026

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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