Tailored Messaging to Reduce Sodium Intake

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099343
• Other study ID #: HUM00123069
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: June 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Medicine, University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in blood pressure	Change in home-measured brachial cuff blood pressure	Baseline, week 8
Other	Estimated dietary sodium intake	Estimated dietary sodium intake from Block Food Frequency Questionnaire (inter-group comparison at week 8, intra-group change from baseline-week 8)	Baseline, week 8
Primary	24-hour urinary sodium excretion	Change from baseline in 24-hour urinary sodium excretion at week 8	Baseline, Week 8
Primary	Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS)	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.	Baseline, Week 8