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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK124469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sipIT | Experimental | Participants receive education and a digital tool to monitor their fluid intake and remind them when they have lapsed in regular fluid intake. |
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| Control | No Intervention | Participants receive usual care (i.e., education about fluid intake guidelines and encouragement to meet those guidelines). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sipIT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hr urine volume | Change in urine volume from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hr urine volume | Change in urine volume from baseline | 1 month and 3 months |
| Urine supersaturations | Change in supersaturations of common stone-forming salts from baseline to 1/3/12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Conroy, PhD | University of Michigan | Principal Investigator |
| Necole M Streeper, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Penn State Hershey Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38253254 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2021 | Dec 17, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 1 month, 3 months, and 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. | 3 months, and 12 months |
| Past-week fluid intake | Change in past-week volume of fluid intake from baseline to 3/12 months | 3 months, and 12 months |
| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| D052801 | Male Urogenital Diseases |