- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06273098
School-Based Bladder Health Intervention
Understanding and Enhancing Schoolchildren's Bathroom Habits: Uncovering Barriers and Promoting Healthy Bladder Habits
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In order to promote healthy bladder behaviors among school children, we will conduct a randomized control trial in schools. The research team will provide support for a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies that are TBD (e.g. mobile technology bathroom passes).
The study will involve 4-8 fourth grade classrooms within 2 elementary schools that meet the historical criteria for >50% students receiving free school lunch.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford Hospital and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 4th grade students from elementary schools that meet the historical criteria for >50% students receiving free school lunch.
Exclusion Criteria:
- Not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bladder Health Education
Participants in this arm will receive the intervention
|
This will be a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies that are TBD (e.g.
mobile technology bathroom passes).
|
|
No Intervention: No Bladder Health Education
Participants in this arm will not receive the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bathroom use
Time Frame: 4 years
|
Individual child's bathroom use (# of bathroom trips measured using mobile technology bathroom passes)
|
4 years
|
|
Symptom score
Time Frame: 4 years
|
Changes in a child's symptom score (survey questions before, during and after the study)
|
4 years
|
|
Urine volume
Time Frame: 4 years
|
Changes in a child's volume of urine (child will void into private bathroom before and during the study to understand if their bladder are too full, no direct observation)
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathleen Kan, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 73162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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