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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61HL155498-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LowSalt4Life | Active Comparator |
| |
| LowSalt4Life + just-in-time adaptive intervention (JITAI) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LowSalt4Life Application | Behavioral | LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure (SBP) | SBP measured by a wireless home blood pressure monitor | Baseline, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight over 2 months | Weight measured using wireless scale | Baseline, 2 months |
| Change in estimated sodium intake | As measured by the Block 2014 Food Frequency Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brahmajee Nallamothu | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2025 | Nov 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
| Just-In-time Adaptive Intervention (JITAI) | Behavioral | LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled. |
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| Baseline, 2 months |
| Change in dietary nutrient intake | As measured by the Block 2014 Food Frequency Questionnaire | Baseline, 2 months |
| Changes in blood pressure (BP) medications | As measured by the electronic health record | Baseline, 2 months |
| Percent of participants at a goal blood pressure (BP) | Goal BPs are based on the American Heart Association blood pressure guidelines. | 2 months |