mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial.

Background: The lack of regular physical activity (PA) in individuals with spinal cord injury (SCI) in the United States is an ongoing health crisis. Regular PA and exercise-based interventions have been linked with improved outcomes and healthier lifestyles among those with SCI. Providing people with an accurate estimate of their everyday PA level can promote PA. Furthermore, PA tracking can be combined with mobile health technology such as smartphones and smartwatches to provide a just-in-time adaptive intervention (JITAI) for individuals with SCI as they go about everyday life. A JITAI can prompt an individual to set a PA goal or provide feedback about their PA levels.
Objective: The primary aim of this study is to investigate whether minutes of moderate-intensity PA among individuals with SCI can be increased by integrating a JITAI with a web-based PA intervention (WI) program. The WI program is a 14-week web-based PA program widely recommended for individuals with disabilities. A secondary aim is to investigate the benefit of a JITAI on proximal PA, defined as minutes of moderate-intensity PA within 120 minutes of a PA feedback prompt.
Methods: Individuals with SCI (N=196) will be randomized to a WI arm or a WI+JITAI arm. Within the WI+JITAI arm, a microrandomized trial will be used to randomize participants several times a day to different tailored feedback and PA recommendations. Participants will take part in the 24-week study from their home environment in the community. The study has three phases: (1) baseline, (2) WI program with or without JITAI, and (3) PA sustainability. Participants will provide survey-based information at the initial meeting and at the end of weeks 2, 8, 16, and 24. Participants will be asked to wear a smartwatch every day for ≥12 hours for the duration of the study.
Results: Recruitment and enrollment began in May 2023. Data analysis is expected to be completed within 6 months of finishing participant data collection.
Conclusions: The JITAI has the potential to achieve long-term PA performance by delivering tailored, just-in-time feedback based on the person's actual PA behavior rather than a generic PA recommendation. New insights from this study may guide intervention designers to develop engaging PA interventions for individuals with disability.
Trial Registration: ClinicalTrials.gov NCT05317832; https://clinicaltrials.gov/study/NCT05317832.
International Registered Report Identifier (irrid): DERR1-10.2196/57699.
(©Rachel L Carey, Ha Le, Donna L Coffman, Inbal Nahum-Shani, Mohanraj Thirumalai, Cole Hagen, Laura A Baehr, Mary Schmidt-Read, Marlyn S R Lamboy, Stephanie A Kolakowsky-Hayner, Ralph J Marino, Stephen S Intille, Shivayogi V Hiremath. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.06.2024.)