Software Application for Low-Sodium Diet Trial (SALT)

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04438551
• Other study ID #: 4979
• Status: Withdrawn
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypernatriuria
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pilot phase - Percent of subjects using the application	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
Primary	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
Primary	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	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
Secondary	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