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Mobile App for Sodium Management for High Blood Pressure

N/A
Recruiting
Led By Brahmajee Nallamothu
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report
Be older than 18 years old
Must not have
Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
Heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a smartphone app to help patients with hypertension manage their sodium intake and improve their blood pressure. The app includes a just in time adaptive intervention (JITAI) to help patients make changes to their sodium intake.

Who is the study for?
This trial is for English-speaking adults with stable high blood pressure, who've been on the same hypertension meds for at least three months. They must own a smartphone compatible with the LowSalt4Life app and be willing to receive notifications. People with unstable blood pressure, secondary causes of hypertension, heart failure, certain kidney issues or those pregnant can't participate.
What is being tested?
The study tests if a mobile app called LowSalt4Life can help manage sodium intake and lower blood pressure in hypertensive patients. It will compare the effectiveness of the app alone versus the app combined with JITAI (just-in-time adaptive intervention).
What are the potential side effects?
Since this trial involves using a mobile application rather than medication, traditional side effects are not expected. However, participants may experience stress or frustration from lifestyle changes or technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have high blood pressure diagnosed by a doctor and have been on stable medication for it for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have conditions like adrenal insufficiency or pheochromocytoma causing my high blood pressure.
Select...
I have heart failure.
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My blood pressure is not higher than 180/120 mmHg.
Select...
My kidney function is very low or I am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in systolic blood pressure (SBP)
Secondary study objectives
Change in dietary nutrient intake
Change in estimated sodium intake
Change in weight over 2 months
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LowSalt4Life + just-in-time adaptive intervention (JITAI)Experimental Treatment2 Interventions
Group II: LowSalt4LifeActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,661 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,931 Total Patients Enrolled
Brahmajee NallamothuPrincipal InvestigatorUniversity of Michigan

Media Library

LowSalt4Life Application Clinical Trial Eligibility Overview. Trial Name: NCT05396001 — N/A
High Blood Pressure Research Study Groups: LowSalt4Life, LowSalt4Life + just-in-time adaptive intervention (JITAI)
High Blood Pressure Clinical Trial 2023: LowSalt4Life Application Highlights & Side Effects. Trial Name: NCT05396001 — N/A
LowSalt4Life Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396001 — N/A
~123 spots leftby Nov 2025
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