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

The Pennsylvania State University (PENNSTATE) logo

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)

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

Trial contacts and locations

1

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Central trial contact

David E Conroy, PhD; Shiyu Li, PhD

Data sourced from clinicaltrials.gov

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