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

May 21, 2026 updated by: David Conroy, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sipIT
Participants will receive an educational handout about physical activity, a connected water bottle with its companion mobile application. For months 1-3, participants will receive lapse-contingent reminders to drink delivered by text message.
Behavioral: sipIT
Automated and manual fluid tracking system with just-in-time reminder messages to support fluid intake habit formation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine volume (intervention)
Time Frame: from baseline to the end of the intervention period (3 months)
Change in urine volume
from baseline to the end of the intervention period (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the end of the intervention period (3 months) to the maintenance change at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

May 29, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00022968
  • R01DK124469 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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