Kidney StoneNCT06269783
Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
A study testing sipIT in people with Kidney Stone and Urolithiasis, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Urolithiasis, Nephrolithiasis
- What is being tested?
- sipIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the detailed 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.
- Conditions
- Kidney Stone, Urolithiasis, Nephrolithiasis
- Being tested
- sipIT
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipITBehavioural
Automated and manual fluid tracking system with just-in-time reminder messages to support fluid intake habit formation.
| Study group | Role | What they receive |
|---|---|---|
| sipIT | Experimental | 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. Receives: Behavioral: sipIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine volume (intervention)
Change in urine volume
Measured: from baseline to the end of the intervention period (3 months)
Secondary outcomes (1)
Urine volume (maintenance)
Change in urine volume
Measured: from the end of the intervention period (3 months) to the maintenance change at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start10 Jan 2024
- Primary completion12 Feb 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Conroy, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269783
- Sponsor's protocol ID
- STUDY00022968
- Other IDs
- R01DK124469
- Status last verified
- May 2026
- First submitted
- 13 Feb 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
- ClinicalTrials.gov ID
- NCT06269783
- Acronym / sponsor ID
- STUDY00022968
- Conditions
- Kidney Stone, Urolithiasis, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sipIT | Experimental | Behavioral: sipITParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sipITAutomated and manual fluid tracking system with just-in-time reminder messages to support fluid intake habit formation. | Behavioural | sipIT |
Primary outcome
Urine volume (intervention)
Time frame: from baseline to the end of the intervention period (3 months)
Change in urine volume
1 secondary outcome
Urine volume (maintenance)
Time frame: from the end of the intervention period (3 months) to the maintenance change at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sipIT in people with Kidney Stone and Urolithiasis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine volume (intervention) (time frame: from baseline to the end of the intervention period (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.