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Study is on hold until pilot study is completed
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dietary counseling | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dietary counseling | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Rajat Jain, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24857648 | Background | Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20. | |
| 24938177 | Background |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single-center prospective randomized controlled trial
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| Mobile app | Behavioral | 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. |
|
| 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 |
| Friedlander JI, Antonelli JA, Pearle MS. Diet: from food to stone. World J Urol. 2015 Feb;33(2):179-85. doi: 10.1007/s00345-014-1344-z. Epub 2014 Jun 18. |
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| 28631933 | Background | Eyles H, McLean R, Neal B, Jiang Y, Doughty RN, McLean R, Ni Mhurchu C. A salt-reduction smartphone app supports lower-salt food purchases for people with cardiovascular disease: Findings from the SaltSwitch randomised controlled trial. Eur J Prev Cardiol. 2017 Sep;24(13):1435-1444. doi: 10.1177/2047487317715713. Epub 2017 Jun 20. |
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| 23299287 | Background | Claro RM, Linders H, Ricardo CZ, Legetic B, Campbell NR. Consumer attitudes, knowledge, and behavior related to salt consumption in sentinel countries of the Americas. Rev Panam Salud Publica. 2012 Oct;32(4):265-73. doi: 10.1590/s1020-49892012001000004. |
| 17449506 | Background | Cook NR, Cutler JA, Obarzanek E, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ. 2007 Apr 28;334(7599):885-8. doi: 10.1136/bmj.39147.604896.55. Epub 2007 Apr 20. |
| 30530462 | Background | Dorsch MP, An LC, Hummel SL. A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial). JMIR Res Protoc. 2018 Dec 7;7(12):e11282. doi: 10.2196/11282. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |