A Mobile Health Intervention to Reduce Sedentary Behavior Among Adolescents and Early Young Adults Receiving Treatment for Acute Lymphoblastic Leukemia: Protocol for a Single-Arm Feasibility Trial.
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BACKGROUND: Sedentary behavior (SB) is highly prevalent among adolescent and early young adult (eAYA) patients with acute lymphoblastic leukemia (ALL) during treatment and contributes to cardiometabolic complications and morbidity among long-term survivors. SB is distinct from physical inactivity and independently associated with adverse health outcomes, yet few interventions in pediatric oncology have directly targeted reducing SB. OBJECTIVE: The RESET in ALL trial was designed as a two-part study to address this research gap. This protocol describes part 1 (1A and 1B, feasibility trial and optimization phase, respectively), including trial design, analysis plan, and anticipated approach to intervention refinement. METHODS: Part 1A was a 12-week, single-arm feasibility trial evaluating a multicomponent mobile health intervention to reduce SB among 20 eAYA patients (ages 12-21 y) with ALL receiving maintenance therapy at Children's Hospital Los Angeles. The intervention included a Fitbit tracker with inactivity-triggered prompts, 3 individualized coaching sessions, and a novel app-based peer support group. Primary outcomes were feasibility (retention, enrollment, and tracker wear time) and acceptability (exit surveys and interviews). Secondary outcomes were accelerometer-measured sedentary time and self-reported sitting time. Exploratory outcomes were cardiometabolic biomarkers, anthropometrics, health-related quality of life, and psychosocial and environmental correlates of SB. Part 1B was a synthetic step in which participant feedback and outcome data from part 1A guided optimization of the intervention prior to being tested via a randomized controlled trial in the future part 2 trial. RESULTS: The study received initial funding in June 2024 and additional funding in July 2025. Participant enrollment and data collection began in September 2024 and were completed in December 2025. Participant enrollment, data collection, and data analysis have been completed. The manuscript reporting the primary trial outcomes is currently under peer review. CONCLUSIONS: This protocol describes the first multicomponent mobile health intervention to reduce SB metrics in eAYAs undergoing cancer treatment. Part 1 (1A and 1B) of the RESET in ALL trial provides the foundation for the development and feasibility evaluation of a novel on-therapy SB intervention, integrating wearable technology, individualized coaching, and peer support. Using a sequential design, in which prior trials inform the optimization of subsequent trials, we aim to develop and refine a scalable, clinically integrated approach to behavior change during treatment that enhances health outcomes in eAYA populations.