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

NCT06269783 | Completed

• 2 other identifiers: STUDY00022968R01DK124469
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Urolithiasis; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Urine volume (intervention)

  Change in urine volume

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

Secondary Outcomes (1)

• Urine volume (maintenance)

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

Study Arms (1)

sipIT

EXPERIMENTAL

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

Interventions

sipIT BEHAVIORAL

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

sipIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Kidney Calculi; Urolithiasis; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: January 10, 2024
• Primary Completion: February 12, 2025
• Study Completion: May 29, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)