American heart journal · 2025
A just-in-time adaptive mobile application intervention to reduce sodium intake and blood pressure in patients with hypertension: Rationale and design of the LowSalt4Life 2 trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Dorsch Michael P, Dempsey Walter, Krambrink Amy, Ganai Sabah, Greer Kaitlyn M, Ali Mohamed S, Gesierich Chelsie, O'Neill Margaret, Nallamothu Brahmajee K, Hummel Scott L
Аннотация
BACKGROUND: Excess dietary sodium intake is a major contributor to hypertension (HTN) and cardiovascular disease in the U.S., yet most Americans exceed recommended sodium intake levels. Despite the established benefits of sodium reduction, behavioral adherence remains a challenge. Just-in-time adaptive interventions (JITAIs) provide a novel mobile health (mHealth) strategy to support low-sodium choices in real-time at restaurants and grocery stores.
METHODS: LowSalt4Life 2 is a 6-month randomized controlled trial evaluating a mobile application-based sodium-focused JITAI among adults with HTN. In phase one, participants were randomized 1:1 to either the LowSalt4Life app with JITAI (App+JITAI) or the app alone. At 2 months, the App+JITAI group was re-randomized to either continue with the standard JITAI or receive a personalized JITAI (pJITAI) informed by reinforcement learning based on prior engagement. The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary sodium intake, and engagement metrics.
RESULTS: As of October 2025, 410 participants had been enrolled and completed follow-up. The trial's final results are anticipated in Spring 2025. Primary analysis focuses on the change in SBP between the App+JITAI and App-only groups, as well as the added value of personalization in the second study phase.
CONCLUSIONS: LowSalt4Life 2 tests a scalable, context-aware digital intervention designed to reduce dietary sodium and improve BP management. By personalizing engagement based on user behavior, this study seeks to advance mHealth strategies for HTN self-management and inform future interventions targeting dietary behaviors in real-world settings.
METHODS: LowSalt4Life 2 is a 6-month randomized controlled trial evaluating a mobile application-based sodium-focused JITAI among adults with HTN. In phase one, participants were randomized 1:1 to either the LowSalt4Life app with JITAI (App+JITAI) or the app alone. At 2 months, the App+JITAI group was re-randomized to either continue with the standard JITAI or receive a personalized JITAI (pJITAI) informed by reinforcement learning based on prior engagement. The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary sodium intake, and engagement metrics.
RESULTS: As of October 2025, 410 participants had been enrolled and completed follow-up. The trial's final results are anticipated in Spring 2025. Primary analysis focuses on the change in SBP between the App+JITAI and App-only groups, as well as the added value of personalization in the second study phase.
CONCLUSIONS: LowSalt4Life 2 tests a scalable, context-aware digital intervention designed to reduce dietary sodium and improve BP management. By personalizing engagement based on user behavior, this study seeks to advance mHealth strategies for HTN self-management and inform future interventions targeting dietary behaviors in real-world settings.