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

NCT ID: NCT06269783

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-05-29

Brief Summary

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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

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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.

Conditions

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Kidney Stone Urolithiasis Nephrolithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

sipIT

Intervention Type BEHAVIORAL

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

Interventions

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sipIT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David Conroy

Bickner Chair of Kinesiology and Professor of Kinesiology, School of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK124469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00022968

Identifier Type: -

Identifier Source: org_study_id

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