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Tailored Messaging to Reduce Sodium Intake

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Location-based Tailored Messaging
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring sodium, salt, diet, tailored messaging, mobile application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Michigan Medicine, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Location-based Tailored Messaging

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

24-hour urinary sodium excretion
Change from baseline in 24-hour urinary sodium excretion at week 8
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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2017
Last Updated
June 4, 2019
Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03099343
Brief Title
Tailored Messaging to Reduce Sodium Intake
Official Title
Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
sodium, salt, diet, tailored messaging, mobile application

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Location-based Tailored Messaging
Arm Type
Experimental
Arm Description
Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study.
Intervention Type
Behavioral
Intervention Name(s)
Location-based Tailored Messaging
Intervention Description
The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.
Primary Outcome Measure Information:
Title
24-hour urinary sodium excretion
Description
Change from baseline in 24-hour urinary sodium excretion at week 8
Time Frame
Baseline, Week 8
Title
Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS)
Description
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.
Time Frame
Baseline, Week 8
Other Pre-specified Outcome Measures:
Title
Change from baseline in blood pressure
Description
Change in home-measured brachial cuff blood pressure
Time Frame
Baseline, week 8
Title
Estimated dietary sodium intake
Description
Estimated dietary sodium intake from Block Food Frequency Questionnaire (inter-group comparison at week 8, intra-group change from baseline-week 8)
Time Frame
Baseline, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott L Hummel, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael P Dorsch, PharmD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36184219
Citation
Alhashimi L, Cordwin DJ, Dandu C, Hummel SL, Dorsch MP. Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension. Clin Nutr ESPEN. 2022 Oct;51:295-300. doi: 10.1016/j.clnesp.2022.08.011. Epub 2022 Aug 12.
Results Reference
derived
PubMed Identifier
32663139
Citation
Dorsch MP, Cornellier ML, Poggi AD, Bilgen F, Chen P, Wu C, An LC, Hummel SL. Effects of a Novel Contextual Just-In-Time Mobile App Intervention (LowSalt4Life) on Sodium Intake in Adults With Hypertension: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Aug 10;8(8):e16696. doi: 10.2196/16696.
Results Reference
derived
PubMed Identifier
30530462
Citation
Dorsch MP, An LC, Hummel SL. A Novel Just-in-Time Contextual Mobile App Intervention to Reduce Sodium Intake in Hypertension: Protocol and Rationale for a Randomized Controlled Trial (LowSalt4Life Trial). JMIR Res Protoc. 2018 Dec 7;7(12):e11282. doi: 10.2196/11282.
Results Reference
derived

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Tailored Messaging to Reduce Sodium Intake

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