Mobile app to help reduce sodium intake and manage blood pressure
A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
This study is testing a smartphone app to see if it can help people with high blood pressure lower their sodium intake and improve their blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05396001 on ClinicalTrials.gov |
What this trial studies
This research aims to determine if a smartphone application, with and without a just-in-time adaptive intervention (JITAI), can assist patients with hypertension in managing their sodium intake and improving their blood pressure. The study will involve a micro-randomized trial to identify effective push notification messages that encourage user engagement with the app's content. Participants will be monitored for two months for primary and secondary outcomes, followed by an additional four months for exploratory measures. The app is designed to provide tailored support to users based on their interactions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with essential hypertension who are on stable antihypertensive therapy and own a compatible smartphone.
Not a fit: Patients with unstable symptoms, contraindications to a sodium-restricted diet, or secondary causes of hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve blood pressure management for patients with hypertension.
How similar studies have performed: Other studies utilizing mobile health interventions for hypertension management have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications 3. A valid email address 4. Fluent in spoken and written English Exclusion Criteria: 1. Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 mmHg) 2. Contraindication to a sodium restriction diet 3. An estimated sodium intake less than 1,500mg per day 4. Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma) 5. Estimated glomerular filtration rate (EGFR) \<30 or end-stage renal disease on dialysis 6. Heart failure 7. Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications 8. Currently pregnant or intent to become pregnant during the study period
Where this trial is running
Ann Arbor, Michigan
- The University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Brahmajee Nallamothu — University of Michigan
- Study coordinator: Sabah Ganai
- Email: sganai@med.umich.edu
- Phone: 734-763-5317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.