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

University of Michigan172 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

172

Conditions

Kidney Stone Urolithiasis Nephrolithiasis

Interventions

sipITBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Pennsylvania State University

University Park, Pennsylvania, United States

Outcomes

Primary Outcomes

Urine volume (intervention)

Change in urine volume

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

Secondary Outcomes

Urine volume (maintenance)

Change in urine volume

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

Data from ClinicalTrials.gov

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