Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-02-12
2024-12-31
Brief Summary
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Detailed Description
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1. Mean change in score on a Knowledge of Low Sodium Diet validated questionnaire completed at baseline and at the end of the study (primary outcome)
\-- The minimum and maximum scores are 0 and 26, respectively. A higher score indicates a better knowledge of LSD and we hypothesize that use of the software application will result in a higher score on the questionnaire.
2. Mean change in urinary sodium measured on two baseline 24hr collections and two end of study 24hr collections (primary outcome)
\-- We hypothesize that an always-available application that helps guide subjects in grocery choices will decrease the 24hr sodium level compared to the control group
3. Within-group assessment of how often the Healthcart application is used to create shopping carts and recording of changes in shopping cart sodium score over the study period (secondary outcome)
\-- Healthcare interventions delivered via mobile applications are quite novel at this time and the data regarding uptake and usage is limited. These outcome measures will add to this body of data.
4. Clinical data (exploratory outcomes)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard dietary counseling
Subjects will be given the standard low sodium diet handout with counseling, complete a validated low sodium questionnaire, and a 24-hr urine collection.
Standard dietary counseling
Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection.
Standard dietary counseling plus mobile app
Subjects will be given the standard low sodium diet handout with counseling, complete a validated low sodium questionnaire, and a 24-hr urine collection. Subjects will use a mobile app to build their shopping lists prior to grocery shopping.
Standard dietary counseling
Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection.
Mobile app
Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection. Subjects will be given a mobile app to build grocery lists where the sodium level will be recorded and tracked in the app.
Interventions
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Standard dietary counseling
Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection.
Mobile app
Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection. Subjects will be given a mobile app to build grocery lists where the sodium level will be recorded and tracked in the app.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Kidney Stone Disease (KSD) within previous 6 months via:
* Surgical procedure for KSD -- OR
* Imaging demonstrating KSD (abdominal xray or CT scan)
* Diagnosis of hypernatriuria (elevated urinary sodium \>150mmol/d) on 24-hour urine collection within previous 6 months
* Mobile phone with iOS
* Working email address
* Food purchased at Wegmans grocery stores in the Rochester area during the study period
* Willingness to participate and able to provide informed consent
Exclusion Criteria
* Current use of medications prescribed for prevention of KSD
* Current prescription of low sodium diet due to another medical condition
* Inability or unwillingness to use mobile application
* Do not participate in grocery shopping
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Rajat Jain
Assistant Professor
Principal Investigators
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Rajat Jain, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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References
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Dorsch MP, An LC, Hummel SL. A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial). JMIR Res Protoc. 2018 Dec 7;7(12):e11282. doi: 10.2196/11282.
Other Identifiers
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4979
Identifier Type: -
Identifier Source: org_study_id
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