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

Primary Purpose

Hypertension, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LowSalt4Life Application
Just-In-time Adaptive Intervention (JITAI)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Dietary sodium

Eligibility Criteria

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

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

Sites / Locations

  • The University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LowSalt4Life

LowSalt4Life + just-in-time adaptive intervention (JITAI)

Arm Description

Outcomes

Primary Outcome Measures

Change in systolic blood pressure (SBP)
SBP measured by a wireless home blood pressure monitor

Secondary Outcome Measures

Change in weight over 2 months
Weight measured using wireless scale
Change in estimated sodium intake
As measured by the Block 2014 Food Frequency Questionnaire
Change in dietary nutrient intake
As measured by the Block 2014 Food Frequency Questionnaire
Changes in blood pressure (BP) medications
As measured by the electronic health record
Percent of participants at a goal blood pressure (BP)
Goal BPs are based on the American Heart Association blood pressure guidelines.

Full Information

First Posted
May 24, 2022
Last Updated
August 15, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05396001
Brief Title
LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure
Official Title
A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
The primary and secondary outcomes will be determined in months 1 & 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected. During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure
Keywords
Dietary sodium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants randomized to the App+JITAI will receive push notifications throughout the study, while those in the App alone group will not. The participants will not be told the group in which they are randomized, but they may know the group because of the number of push notifications.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LowSalt4Life
Arm Type
Active Comparator
Arm Title
LowSalt4Life + just-in-time adaptive intervention (JITAI)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
LowSalt4Life Application
Intervention Description
LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.
Intervention Type
Behavioral
Intervention Name(s)
Just-In-time Adaptive Intervention (JITAI)
Intervention Description
LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure (SBP)
Description
SBP measured by a wireless home blood pressure monitor
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
Title
Change in weight over 2 months
Description
Weight measured using wireless scale
Time Frame
Baseline, 2 months
Title
Change in estimated sodium intake
Description
As measured by the Block 2014 Food Frequency Questionnaire
Time Frame
Baseline, 2 months
Title
Change in dietary nutrient intake
Description
As measured by the Block 2014 Food Frequency Questionnaire
Time Frame
Baseline, 2 months
Title
Changes in blood pressure (BP) medications
Description
As measured by the electronic health record
Time Frame
Baseline, 2 months
Title
Percent of participants at a goal blood pressure (BP)
Description
Goal BPs are based on the American Heart Association blood pressure guidelines.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 A valid email address Fluent in spoken and written English Exclusion Criteria: Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 mmHg) Contraindication to a sodium restriction diet An estimated sodium intake less than 1,500mg per day Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma) Estimated glomerular filtration rate (EGFR) <30 or end-stage renal disease on dialysis Heart failure Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications Currently pregnant or intent to become pregnant during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabah Ganai
Phone
734-763-5317
Email
sganai@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brahmajee Nallamothu
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigid Rowell
Phone
734-763-1346
Email
bnallamo@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Brahmajee Nallamothu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The aim is to prepare data for deposit into the National Heart, Lung, and Blood Institute (NHLBI) supported Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC).Unique research data be made available to the scientific community after the conclusion of a study. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Heart, Lung, and Blood Institute data sharing policies.
IPD Sharing Time Frame
Unique research data be made available to the scientific community after the conclusion of a study. No later than 3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
IPD Sharing Access Criteria
The scientific community will have access to the data deposited into the National Heart, Lung, and Blood Institute (NHLBI) supported Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC). Researchers at institutions with a Federal Wide Assurance will be able to gain access to repository data by submitting a data access request in accordance with applicable policies.
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/

Learn more about this trial

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

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