HypertensionNCT03099343
Tailored Messaging to Reduce Sodium Intake
A study testing Location-based Tailored Messaging in people with Hypertension, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Location-based Tailored Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Location-based Tailored Messaging
- Keywords
- sodium, salt, diet, tailored messaging, mobile application
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location-based Tailored MessagingBehavioural
The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.
| Study group | Role | What they receive |
|---|---|---|
| Location-based Tailored Messaging | Experimental | Participants receive location-based tailored messaging via a mobile application throughout the 8-week research study. Receives: Behavioral: Location-based Tailored Messaging |
| Control Group | No intervention | Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary sodium excretion
Change from baseline in 24-hour urinary sodium excretion at week 8
Measured: Baseline, 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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start21 Sep 2017
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Scott L. Hummel, University of Michigan
- Investigators
- Scott L Hummel, MD, MS, Principal investigator, University of MichiganMichael P Dorsch, PharmD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099343
- Sponsor's protocol ID
- HUM00123069
- Status last verified
- Jun 2019
- First submitted
- 28 Mar 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36184219Dorsch 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.
PubMed 32663139Dorsch 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.
PubMed 30530462
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03099343
- Acronym / sponsor ID
- HUM00123069
- Conditions
- Hypertension
- Keywords
- sodium, salt, diet, tailored messaging, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Location-based Tailored Messaging | Experimental | Behavioral: Location-based Tailored MessagingParticipants receive location-based tailored messaging via a mobile application throughout the 8-week research study. |
| Control Group | No intervention | –Participants follow their usual eating pattern and will not have access to the application throughout the 8-week research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (6 listed)
- Chronic Kidney Disease
- Heart Failure
- Systolic Blood Pressure >180 mm Hg
- Diastolic Blood Pressure >110 mm Hg
- Use of a loop diuretic or corticosteroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Location-based Tailored MessagingThe mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods. | Behavioural | Location-based Tailored Messaging |
Primary outcome
24-hour urinary sodium excretion
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 36184219Alhashimi 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.
- Derived from this study: PubMed 32663139Dorsch 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.
- Derived from this study: PubMed 30530462Dorsch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott L Hummel, MD, MS principal investigator
University of Michigan
Michael P Dorsch, PharmD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Location-based Tailored Messaging in people with Hypertension, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary sodium excretion (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099343, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.