Software Application for Low-Sodium Diet Trial (SALT)

August 15, 2023 updated by: Rajat Jain, University of Rochester

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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:

  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)

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in score of Knowledge of Low Sodium Diet Questionnaire
Time Frame: Baseline to 8 weeks
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
Time Frame: Baseline to 8 weeks
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
Time Frame: Baseline to 8 weeks

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
Time Frame: Baseline to 8 weeks

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pilot phase - Percent of subjects using the application
Time Frame: 8 weeks
Once 20 subjects have been enrolled in the intervention arm, we will analyze whether they are using the application and what percentage are completing the study. If 15 or more subjects have completed the trial as intended, enrollment will continue to the final number of 40 per arm. Otherwise, the trial will be terminated.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Rajat Jain, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4979

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Stone

Clinical Trials on Standard dietary counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe