sipIT for Kidney Stones

Overseen By Shiyu Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Pregnancy, Surgery, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how people can change and maintain new drinking habits, particularly increasing fluid intake. Participants will use a smart water bottle and app to track and remind them to drink more over three months. This approach, called sipIT, targets individuals in the continental U.S. who have experienced kidney stones in the past five years and are willing to use the provided tools and receive reminders. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hydration habits and kidney health.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on active medical treatments that would make it hard to follow the study rules, you might not be eligible to participate.

What prior data suggests that this fluid intake intervention is safe?

Research has shown that producing at least 2.5 liters of urine daily by drinking enough water can help prevent kidney stones. The sipIT treatment supports this by using a smart water bottle and a mobile app to remind participants to drink more water. While specific safety details for sipIT are not provided, the treatment emphasizes encouraging healthy habits rather than introducing new drugs or chemicals, suggesting it is likely safe for participants. With no negative effects mentioned, the treatment appears safe for most people and does not involve new or untested substances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sipIT for kidney stones because it offers a novel approach by emphasizing lifestyle modifications rather than medication or surgical interventions. Unlike traditional treatments like pain relievers, hydration advice, or possibly surgery, sipIT combines a connected water bottle with a mobile app to encourage better hydration through personalized reminders. This approach aims to prevent kidney stone formation by ensuring adequate daily water intake, making it a proactive and non-invasive option.

What evidence suggests that the sipIT intervention is effective for increasing fluid intake in kidney stone patients?

Research has shown that the sipIT program, which participants in this trial will receive, can help people drink more fluids, crucial for preventing kidney stones. Studies indicate that producing more than 2.5 liters of urine daily can reduce the risk of kidney stones returning by 50% to 60%. One study found that most participants increased their urine output by using a smart water bottle and receiving text reminders. These results suggest that sipIT might help people consistently drink more fluids, lowering the chance of kidney stones forming again. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who are currently experiencing kidney stones. The specific eligibility criteria to participate in the study have not been provided, so it's important to contact the research team for detailed information on who can join.

Inclusion Criteria

Live in continental US

Proficient in English

I am willing to use a water bottle and app, and get text reminders for 3 months.

Exclusion Criteria

I do not have heart failure, severe kidney disease, or chronic low sodium that would stop me from drinking a lot of fluids.

I am planning to undergo surgery within the next 6 months.

Pregnant or planning to become pregnant during the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors

3 months

Weekly assessments (virtual)

Maintenance

Monthly assessments of motivation and life events or stressors in the three months following the end of intervention

3 months

Monthly assessments (virtual)

Follow-up

Participants are monitored for changes in urine volume from the end of the intervention period to the maintenance change at 6 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• sipIT

Trial Overview The sipIT intervention is being tested in this study. It aims to understand how behavior changes, continues over time, and adherence are influenced during and after a three-month period of using sipIT.

How Is the Trial Designed?

Group I: sipIT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38253254/

Promoting fluid intake to increase urine volume for kidney ... This trial evaluates the efficacy of sip IT for increasing urine output in patients at risk for recurrence of kidney stones.

2. reporter.nih.gov reporter.nih.gov/project-details/10831605

Efficacy of sipIT Intervention for Increasing Urine Output ... Five-year recurrence rates for stones have been as high as 40% and a standard guideline for prevention is to increase fluid intake enough to produce > 2.5 L of ...

3. medicalupdate.pennstatehealth.org medicalupdate.pennstatehealth.org/urology-surgery/hydration-increase-research-0824/

Researchers Test Technological Intervention to Increase ... The system proved successful with a majority of participants in a three-month feasibility study. The research brings hope for helping patients make long-term ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429523005630

Feasibility of Mini sipIT Behavioral Intervention to Increase ... This trial evaluates the efficacy of sipIT for increasing urine output in patients at risk for recurrence of kidney stones.

5. auanews.net auanews.net/issues/articles/2023/october-extra-2023/clinical-trials-sipit-behavioral-intervention-clinical-trial-to-increase-fluid-intake-for-kidney-stone-prevention

CLINICAL TRIALS SipIT Behavioral Intervention ... Kidney stone prevalence continues to rise but producing 2.5 L of urine daily is associated with a 50%-60% decreased risk of stone recurrence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923155/

Promoting fluid intake to increase urine volume for kidney ... This trial evaluates the efficacy of sip IT for increasing urine output in patients at risk for recurrence of kidney stones.

7. withpower.com withpower.com/trial/phase-kidney-calculi-2024-1b253

sipIT for Kidney Stones · Info for Participants The research does not provide specific safety data for sipIT, but it mentions the tolerability of Potassium Citrate tablets in patients with kidney stones, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429519306855

Improving Fluid Intake Behavior Among Patients With ... Increasing fluid intake to produce at least 2.5 L of urine daily is a well-established preventive strategy to reduce the risk of kidney stones. Unfortunately, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11166357/

Feasibility of mini sipIT Behavioral Intervention to Increase ... Mini sip IT behavioral intervention and outcome assessments are feasible for patients and may lead to significant increases in 24-hour urine volume.