Software Application for Low-Sodium Diet Trial (SALT)

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will be designed as a single-center prospective randomized controlled trial. Subjects will be assigned to the standard of care dietary recommendations handout vs a mobile application that analyzes sodium content of shopping lists that are created prior to shopping trips to the grocery store. The intervention will be administered for 8 weeks. The trial will be split into two phases, 1) Pilot phase, and 2) Trial phase. Once we have enrolled 20 subjects in the intervention arm, we will analyze whether an appropriate percentage of subjects have completed the study and adequate data is being collected. At the end of the trial, outcomes will be measured as follows: 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. 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 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. Clinical data (exploratory outcomes)

Official Title
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Software Application for Low-Sodium Diet Trial (SALT): A Pilot Study

Conditions
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Kidney Stone, Hypernatriuria

Intervention / Treatment
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* Behavioral: Standard dietary counseling
* Behavioral: Mobile app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dietary counseling<br>Subjects will be given the standard low sodium diet handout with counseling, complete a validated low sodium questionnaire, and a 24-hr urine collection. | Behavioral: Standard dietary counseling<br>* 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.<br>|
| Experimental: Standard dietary counseling plus mobile app<br>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. | Behavioral: Standard dietary counseling<br>* 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.<br>Behavioral: Mobile app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in score of Knowledge of Low Sodium Diet Questionnaire | Subjects will complete a low sodium diet validated questionnaire, score range from 0 to 26, higher score indicates better knowledge of role of sodium in diet and relationship of sodium to certain foods. | Baseline to 8 weeks | 
| Mean change in twenty four hour urinary sodium levels | Urinary sodium levels measured by collecting two 24-hour urine samples at pre-study and 8 weeks. The two 24-hr samples will be averaged to get a single urinary sodium level at each time point, the change will be recorded for each subject and the mean and standard deviation for the intervention and control groups will be compared | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory within-group assessment of application usage in the intervention group | Healthcare interventions delivered via mobile applications are quite novel at this time and the data regarding uptakes and usage is limited. These outcome measures will add to this body of data. We will record: 1. number of shopping carts created | Baseline to 8 weeks | 
| Exploratory within-group assessment of application usage in the intervention group | Healthcare interventions delivered via mobile applications are quite novel at this time and the data regarding uptakes and usage is limited. These outcome measures will add to this body of data. We will record: 2. number of changes made due to suggestions offered by the application | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney stone, Low sodium diet, Mobile health app, Stone prevention, Behavioral modification