Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-09-21
2019-04-26
Brief Summary
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Detailed Description
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The mobile application will deliver tailored messages based on the user's location and previously identified high-sodium food items that they commonly consume.
This 8-week research study at Visit 1 or baseline will consent and randomize 50 eligible adults with high blood pressure to use the mobile application daily or to follow their usual eating pattern with no access to the application.
All participants will be asked to complete four surveys at baseline and Week 8: Block Food Frequency Questionnaire, Block Sodium Screener, Self-care Confidence in following a Low Sodium Diet and the Automated Self-administered 24-Hour Dietary Recall survey. All participants will be asked to provide a baseline and end of study 24-hour urine collection, regularly provide home blood pressure measurements and urine dipstick tests every two weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Location-based Tailored Messaging
Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.
Location-based Tailored Messaging
The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.
Control Group
Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.
No interventions assigned to this group
Interventions
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Location-based Tailored Messaging
The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.
Eligibility Criteria
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Inclusion Criteria
* Hypertension
* Use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks
* Daily sodium intake of \>2,000 mg with sodium to kcal ratio \> 1, estimated via Food Frequency Questionnaire
* Ownership and use of an Apple iPhone
Exclusion Criteria
* Heart Failure
* Systolic Blood Pressure \>180 mm Hg
* Diastolic Blood Pressure \>110 mm Hg
* Use of a loop diuretic or corticosteroid
* Insulin dependent diabetes mellitus
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of Michigan
OTHER
Responsible Party
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Scott L. Hummel
MD MS Assistant Professor Internal Medicine Cardiology
Principal Investigators
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Scott L Hummel, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Michael P Dorsch, PharmD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Alhashimi L, Cordwin DJ, Dandu C, Hummel SL, Dorsch MP. Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension. Clin Nutr ESPEN. 2022 Oct;51:295-300. doi: 10.1016/j.clnesp.2022.08.011. Epub 2022 Aug 12.
Dorsch MP, Cornellier ML, Poggi AD, Bilgen F, Chen P, Wu C, An LC, Hummel SL. Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Aug 10;8(8):e16696. doi: 10.2196/16696.
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.
Other Identifiers
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HUM00123069
Identifier Type: -
Identifier Source: org_study_id
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