Tailored Messaging to Reduce Sodium Intake
|ClinicalTrials.gov Identifier: NCT03099343|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Location-based Tailored Messaging||Not Applicable|
People with high blood pressure often get advice to lower their salt or sodium intake. High dietary sodium intake is linked to high blood pressure, stroke, heart failure and kidney disease. U.S. federal guidelines advocate daily sodium intake of less than 2,300 milligrams (mg). The estimated average sodium intake for Americans is 3,400 mg per day. In recent years, consumption of processed and restaurant foods has substantially increased. More than 75% of sodium in the average U.S. diet now comes from these sources.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients|
|Actual Study Start Date :||September 21, 2017|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||April 26, 2019|
Experimental: Location-based Tailored Messaging
Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.
Behavioral: 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.
No Intervention: Control Group
Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.
- 24-hour urinary sodium excretion [ Time Frame: Baseline, Week 8 ]Change from baseline in 24-hour urinary sodium excretion at week 8
- Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) [ Time Frame: Baseline, Week 8 ]Change from baseline in Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) at week 8. It assesses the participants' confidence in the ability to select and prepare low-sodium foods. The self-reported tool consists of 7 items with 4 response options per item. The score range is 1-4 (1=Not confident, 2=Somewhat confident, 3=Very confident, 4=Extremely confident) then added for each question. Possible scores range from 7 to 28 and the higher the score indicates greater confidence.
- Change from baseline in blood pressure [ Time Frame: Baseline, week 8 ]Change in home-measured brachial cuff blood pressure
- Estimated dietary sodium intake [ Time Frame: Baseline, week 8 ]Estimated dietary sodium intake from Block Food Frequency Questionnaire (inter-group comparison at week 8, intra-group change from baseline-week 8)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099343
|United States, Michigan|
|Michigan Medicine, University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Scott L Hummel, MD, MS||University of Michigan|
|Principal Investigator:||Michael P Dorsch, PharmD, MS||University of Michigan|