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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05196113
Other study ID # STUDY00015540
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 4, 2022
Est. completion date June 15, 2025

Study information

Verified date June 2024
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility of using sipIT tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis.


Description:

The study uses a randomized controlled trial design with a 12-month intervention period and outcome assessments at baseline, 1, 3, and 12 months. Participants will be randomly assigned to groups. Both groups will receive usual care which involves education about fluid intake guidelines and encouragement to adhere to those guidelines from a clinician. The intervention group will additionally receive the sipIT intervention comprising a semi-automated fluid intake tracking system and context-sensitive, just-in-time notifications reminding them to drink.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 216
Est. completion date June 15, 2025
Est. primary completion date September 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - previous diagnosis of symptomatic kidney stone in past 5 yrs - 24-hr urine volume = 2.0 L/day, - age 18 or older, - own iOS or Android smartphone, - proficient in English language, - capable of providing informed consent, and - willing to use a Fitbit smartwatch, connected water bottle, and mobile app for the study every day for a year, and receive text messages reminder to drink. Exclusion Criteria: - previous diagnosis with cystine stone, - pregnant or planning to become pregnant in the next 12 months, - concurrently participating in another study involving fluid intake or diet, - plan to have surgery or relocate outside the area within the next year - co-morbidities that preclude high fluid intake, conditions with high fluid losses (e.g., congestive heart failure, bariatric surgery, GI tract ostomy, short gut syndrome, chronic diarrhea including patients with ulcerative colitis/Crohn's disease, hyponatremia), or conditions that preclude ability to collect 24-hour urine (severe urinary incontinence), - active medical treatments that would impair protocol compliance, - chronic use of lithium, or - psychiatric conditions impairing compliance with the study protocol.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
sipIT
Participants receive education and digital tools to monitor their fluid intake and just-in-time text messages to remind them when they have lapsed in regular fluid intake.

Locations

Country Name City State
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Pennsylvania State University University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Conroy DE, Marks J, Cutshaw A, Ram N, Thomaz E, Streeper NM. Promoting fluid intake to increase urine volume for kidney stone prevention: Protocol for a randomized controlled efficacy trial of the sipIT intervention. Contemp Clin Trials. 2024 Mar;138:107454. doi: 10.1016/j.cct.2024.107454. Epub 2024 Jan 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 24-hr urine volume Change in urine volume from baseline 3 months
Secondary 24-hr urine volume Change in urine volume from baseline 1 month and 12 months
Secondary Urine supersaturations Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months 1 month, 3 months, and 12 months
Secondary Habit strength for fluid intake Change in habit by the 4-item Self-Report Behavioural Automaticity Index (Gardner, Abraham, Lally & de Bruijn, 2012, Int J Beh Nutr Phys Act; baseline to 3/12 months). Responses will be averaged so scores range from 1 (strongly disagree) to 7 (strongly agree) with higher scores indicating stronger habits for fluid intake. 3 months, and 12 months
Secondary Past-week fluid intake Change in past-week volume of fluid intake from baseline to 3/12 months 3 months, and 12 months
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