WithdrawnNot Applicable

Software Application for Low-Sodium Diet Trial (SALT)

Stopped: Study is on hold until pilot study is completed

United States0Started 2021-02-12

Plain-language summary

This a single-center prospective randomized controlled trial. Subjects will be assigned to the standard of care dietary recommendations for a low sodium diet (LSD) vs. the standard of care dietary recommendations for a low sodium diet plus a mobile application that analyzes sodium content of shopping lists that are created prior to shopping trips to the grocery store over an 8-week study period. An initial pilot phase will be done to ensure adequate percentage of subjects are completing the study in the intervention group and that adequate data is being collected.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female adults aged 18 or greater and any race/ethnicity * 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: * Pregnancy * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in score of Knowledge of Low Sodium Diet Questionnaire

Timeframe: Baseline to 8 weeks

Mean change in twenty four hour urinary sodium levels

Timeframe: Baseline to 8 weeks

Trial details

NCT IDNCT04438551

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Kidney Stone trials