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

Not Applicable

Active, not recruiting

• Conditions: Kidney Stone; Urolithiasis; Nephrolithiasis
• Interventions: Behavioral: sipIT

• Registration Number: NCT06269783
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study Start: 2024-01-10
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sipIT	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.

Primary Outcome Measures

Name	Time	Method
Urine volume (intervention)	from baseline to the end of the intervention period (3 months)	Change in urine volume

Secondary Outcome Measures

Name	Time	Method
Urine volume (maintenance)	from the end of the intervention period (3 months) to the maintenance change at 6 months	Change in urine volume

Trial Locations

Locations (1)

The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States