Tailored Messaging to Reduce Sodium Intake

University of Michigan

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Location-based Tailored Messaging

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03099343

HUM00123069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Location-based Tailored Messaging

Experimental group

Description:

Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.

Treatment:

Behavioral: Location-based Tailored Messaging

Control Group

No Intervention group

Description:

Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.