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Software Application for Low-Sodium Diet Trial (SALT)

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ClinicalTrials.gov Identifier: NCT04438551
Recruitment Status : Suspended (Study is on hold until pilot study is completed.)
First Posted : June 19, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Rajat Jain, 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.

Condition or disease Intervention/treatment Phase
Kidney Stone Hypernatriuria Behavioral: Standard dietary counseling Behavioral: Mobile app Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center prospective randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Software Application for Low-Sodium Diet Trial (SALT): A Pilot Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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


  2. 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



Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438551


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Rajat Jain, MD University of Rochester
Publications:
Murray CJ, Atkinson C, Bhalla K, Birbeck G, Burstein R, Chou D, Dellavalle R, Danaei G, Ezzati M, Fahimi A, Flaxman D, Foreman, Gabriel S, Gakidou E, Kassebaum N, Khatibzadeh S, Lim S, Lipshultz SE, London S, Lopez, MacIntyre MF, Mokdad AH, Moran A, Moran AE, Mozaffarian D, Murphy T, Naghavi M, Pope C, Roberts T, Salomon J, Schwebel DC, Shahraz S, Sleet DA, Murray, Abraham J, Ali MK, Atkinson C, Bartels DH, Bhalla K, Birbeck G, Burstein R, Chen H, Criqui MH, Dahodwala, Jarlais, Ding EL, Dorsey ER, Ebel BE, Ezzati M, Fahami, Flaxman S, Flaxman AD, Gonzalez-Medina D, Grant B, Hagan H, Hoffman H, Kassebaum N, Khatibzadeh S, Leasher JL, Lin J, Lipshultz SE, Lozano R, Lu Y, Mallinger L, McDermott MM, Micha R, Miller TR, Mokdad AA, Mokdad AH, Mozaffarian D, Naghavi M, Narayan KM, Omer SB, Pelizzari PM, Phillips D, Ranganathan D, Rivara FP, Roberts T, Sampson U, Sanman E, Sapkota A, Schwebel DC, Sharaz S, Shivakoti R, Singh GM, Singh D, Tavakkoli M, Towbin JA, Wilkinson JD, Zabetian A, Murray, Abraham J, Ali MK, Alvardo M, Atkinson C, Baddour LM, Benjamin EJ, Bhalla K, Birbeck G, Bolliger I, Burstein R, Carnahan E, Chou D, Chugh SS, Cohen A, Colson KE, Cooper LT, Couser W, Criqui MH, Dabhadkar KC, Dellavalle RP, Jarlais, Dicker D, Dorsey ER, Duber H, Ebel BE, Engell RE, Ezzati M, Felson DT, Finucane MM, Flaxman S, Flaxman AD, Fleming T, Foreman, Forouzanfar MH, Freedman G, Freeman MK, Gakidou E, Gillum RF, Gonzalez-Medina D, Gosselin R, Gutierrez HR, Hagan H, Havmoeller R, Hoffman H, Jacobsen KH, James SL, Jasrasaria R, Jayarman S, Johns N, Kassebaum N, Khatibzadeh S, Lan Q, Leasher JL, Lim S, Lipshultz SE, London S, Lopez, Lozano R, Lu Y, Mallinger L, Meltzer M, Mensah GA, Michaud C, Miller TR, Mock C, Moffitt TE, Mokdad AA, Mokdad AH, Moran A, Naghavi M, Narayan KM, Nelson RG, Olives C, Omer SB, Ortblad K, Ostro B, Pelizzari PM, Phillips D, Raju M, Razavi H, Ritz B, Roberts T, Sacco RL, Salomon J, Sampson U, Schwebel DC, Shahraz S, Shibuya K, Silberberg D, Singh JA, Steenland K, Taylor JA, Thurston GD, Vavilala MS, Vos T, Wagner GR, Weinstock MA, Weisskopf MG, Wulf S, Murray; U.S. Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013 Aug 14;310(6):591-608. doi: 10.1001/jama.2013.13805.

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Responsible Party: Rajat Jain, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04438551    
Other Study ID Numbers: 4979
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajat Jain, University of Rochester:
Kidney stone
Low sodium diet
Mobile health app
Stone prevention
Behavioral modification
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical