Back to resultssipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Primary Purpose
Urolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sipIT
Sponsored by
About this trial
This is an interventional prevention trial for Urolithiasis
Eligibility Criteria
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 wear a Fitbit smartwatch daily for 1 year.
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 (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.
Sites / Locations
- Penn State Hershey Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sipIT
Control
Arm Description
Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake.
Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).
Outcomes
Primary Outcome Measures
24-hr urine volume
Change in urine volume from baseline
Secondary Outcome Measures
24-hr urine volume
Change in urine volume from baseline
Urine supersaturations
Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months
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.
Past-week fluid intake
Change in past-week volume of fluid intake from baseline to 3/12 months
Full Information
NCT ID
NCT05196113
First Posted
December 3, 2021
Last Updated
August 19, 2023
Sponsor
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT05196113
Brief Title
sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Official Title
sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
November 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sipIT
Arm Type
Experimental
Arm Description
Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines).
Intervention Type
Behavioral
Intervention Name(s)
sipIT
Intervention Description
Intervention has two components: (a) education about fluid intake guidelines and encouragement them to adhere to those guidelines (i.e., drink enough to produce >2.5 L of urine daily), and (b) just-in-time adaptive intervention using a semi-automated tracking system to detect drinking and, following lapses, trigger reminder messages
Primary Outcome Measure Information:
Title
24-hr urine volume
Description
Change in urine volume from baseline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
24-hr urine volume
Description
Change in urine volume from baseline
Time Frame
1 month and 12 months
Title
Urine supersaturations
Description
Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months
Time Frame
1 month, 3 months, and 12 months
Title
Habit strength for fluid intake
Description
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.
Time Frame
3 months, and 12 months
Title
Past-week fluid intake
Description
Change in past-week volume of fluid intake from baseline to 3/12 months
Time Frame
3 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 wear a Fitbit smartwatch daily for 1 year.
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 (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Marks, BS
Phone
717-531-0003
Ext
284233
Email
UrologyResearch@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Conroy, PhD
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Necole M Streeper, MD
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Marks, BS
Phone
717-531-0003
Ext
284233
Email
UrologyResearch@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
David E Conroy, PhD
First Name & Middle Initial & Last Name & Degree
Necole M Streeper, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
sipIT2: Improving Adherence to Fluid Intake Guidelines for Kidney Stone Prevention
We'll reach out to this number within 24 hrs