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Tailored Messaging to Reduce Sodium Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099343
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Scott L. Hummel, University of Michigan

Brief Summary:
The proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Location-based Tailored Messaging Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 24-hour urinary sodium excretion [ Time Frame: Baseline, Week 8 ]
    Change from baseline in 24-hour urinary sodium excretion at week 8

  2. 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.


Other Outcome Measures:
  1. Change from baseline in blood pressure [ Time Frame: Baseline, week 8 ]
    Change in home-measured brachial cuff blood pressure

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • > 18 years of age
  • 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:

  • Chronic Kidney Disease
  • 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

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): NCT03099343


Locations
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United States, Michigan
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Scott L Hummel, MD, MS University of Michigan
Principal Investigator: Michael P Dorsch, PharmD, MS University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott L. Hummel, MD MS Assistant Professor Internal Medicine Cardiology, University of Michigan
ClinicalTrials.gov Identifier: NCT03099343    
Other Study ID Numbers: HUM00123069
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Scott L. Hummel, University of Michigan:
sodium
salt
diet
tailored messaging
mobile application
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases