COMPLETED

LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.

Official Title

A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life

Quick Facts

Study Start:2022-08-15
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05396001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. A valid email address
  4. 4. Fluent in spoken and written English
  1. 1. Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 mmHg)
  2. 2. Contraindication to a sodium restriction diet
  3. 3. An estimated sodium intake less than 1,500mg per day
  4. 4. Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
  5. 5. Estimated glomerular filtration rate (EGFR) \<30 or end-stage renal disease on dialysis
  6. 6. Heart failure
  7. 7. Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications
  8. 8. Currently pregnant or intent to become pregnant during the study period

Contacts and Locations

Principal Investigator

Brahmajee Nallamothu
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

The University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Brahmajee Nallamothu, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-15
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Dietary sodium

Additional Relevant MeSH Terms

  • Hypertension
  • Blood Pressure