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

The Pennsylvania State University (PENNSTATE)

Status: Enrolling

Conditions: Urolithiasis; Kidney Stone; Nephrolithiasis

Treatments: Behavioral: sipIT

Study type: Interventional

Funder types: Other

Identifiers

NCT06269783

STUDY00022968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

sipIT

Experimental group

Description:

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.

Treatment:

Behavioral: sipIT