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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06269783
Enrollment
172
Registered
2024-02-21
Start date
2024-01-10
Completion date
2025-05-29
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone, Nephrolithiasis, Urolithiasis

Brief summary

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.

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.

Interventions

BEHAVIORALsipIT

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

Sponsors

University of Michigan
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Urine volume (intervention)from baseline to the end of the intervention period (3 months)Change in urine volume

Secondary

MeasureTime frameDescription
Urine volume (maintenance)from the end of the intervention period (3 months) to the maintenance change at 6 monthsChange in urine volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026