Software Application for Low-Sodium Diet Trial (SALT)

Not Applicable

Withdrawn

• Conditions: Hypernatriuria; Kidney Stone
• Interventions: Behavioral: Standard dietary counseling; Behavioral: Mobile app

• Registration Number: NCT04438551
• Lead Sponsor: University of Rochester

Brief 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.

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 Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2021-02-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dietary counseling	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 plus mobile app	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 plus mobile app	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. Subjects will use a mobile app to build their shopping lists prior to grocery shopping.

Primary Outcome Measures

Name	Time	Method
Mean change in score of Knowledge of Low Sodium Diet Questionnaire	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.
Mean change in twenty four hour urinary sodium levels	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

Secondary Outcome Measures

Name	Time	Method
Exploratory within-group assessment of application usage in the intervention group	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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States