Hypernatriuria, Kidney Stone
Conditions
Keywords
Kidney stone, Low sodium diet, Mobile health app, Stone prevention, Behavioral modification
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)
Interventions
BEHAVIORALStandard 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.
BEHAVIORALMobile 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: 1\. number of shopping carts created |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pilot phase - Percent of subjects using the application | 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. |
Countries
United States
Outcome results
None listed