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Completed

NCT Number: NCT03099343

Tailored Messaging to Reduce Sodium Intake

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Location-based Tailored Messaging

Behavioral

The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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