Tailored Messaging to Reduce Sodium Intake

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Location-based Tailored Messaging

• Registration Number: NCT03099343
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-09-21
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Location-based Tailored Messaging	Location-based Tailored Messaging	Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.

Primary Outcome Measures

Name	Time	Method
24-hour urinary sodium excretion	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)	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.

Trial Locations

Locations (1)

Michigan Medicine, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States