The goal of this clinical trial is to learn whether an optimized, multi-component mobile health intervention (ReSeT2) can reduce sedentary behavior in adolescents and young adults with acute lymphoblastic leukemia (ALL) who are receiving maintenance therapy. The participant population includes English-speaking adolescents and young adults aged 13-22 years with ALL or related lymphoid malignancies being treated at Children's Hospital Los Angeles.
The main questions it aims to answer are:
* Does the ReSeT2 intervention reduce device-measured total sedentary time (minutes/day) from baseline to Week 12 compared with usual care? * Does the ReSeT2 intervention improve other sedentary behavior measures, feasibility and acceptability outcomes, and exploratory health outcomes such as cardiometabolic health, quality of life, and self-efficacy?
Researchers will compare participants receiving the ReSeT2 intervention with participants receiving usual care to see if the intervention leads to greater reductions in sedentary time and improvements in related health outcomes.
Participants will:
* Complete baseline and Week 12 assessments, including questionnaires, clinical measurements, laboratory tests, and 7-day accelerometer wear periods. * Be randomized to either the ReSeT2 intervention group or usual care. * If assigned to the intervention group:
Use a Fitbit activity tracker with inactivity prompts for 10 weeks. Receive home activity equipment and goal-based incentives. Participate in individualized coaching sessions. Participate in a peer support GroupMe chat and optional in-person group sessions.
If assigned to the usual care group, continue standard clinical care and complete study assessments.
Age 13-22 years at the time of enrollment.
Diagnosis of lymphoblastic leukemia or lymphoma treated with Children's Oncology Group (COG)-based maintenance chemotherapy (B-ALL, T-ALL, MPAL).
Patients with a history of relapsed disease are eligible if currently in second (or greater) remission and receiving COG-based maintenance therapy.
Completed at least 1 month of maintenance therapy (through maintenance cycle 1, day 29) and have at least one maintenance cycle (approximately 3 months) remaining.
Evidence of recurrent or metastatic disease.
Inability to obtain informed consent/assent.
Medical contraindication to daily standing and light physical activity (>1.5 METs).
Intellectual disability or developmental delay that limits the ability to fully participate in the study intervention.
Parallel
ReSeT2 Intervention
BehavioralA 10-week multi-component mobile health sedentary behavior intervention that includes a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, individualized coaching, a peer-support GroupMe chat, and optional in-person group sessions
Change in Total Sedentary Time
Change from Baseline to Week 12 in average daily total sedentary time (minutes/day), measured by the ActivPAL4 thigh-worn accelerometer. Daily sedentary time will be averaged across valid wear days (defined as ≥4 days with ≥10 hours/day of waking wear time) and compared between the ReSeT2 intervention and usual care control groups. The primary analysis will compare the change from Baseline to Week 12 between study arms.
Change in Daily Sitting Time Measured by Accelerometry
Change from Baseline to Week 12 in average daily sitting time (minutes/day) measured using the ActivPAL4 accelerometer and compared between intervention and control groups.
Change in Time Spent in Prolonged Sedentary Bouts
Change from Baseline to Week 12 in average daily time spent in prolonged sedentary bouts exceeding 60 minutes (minutes/day), measured by ActivPAL4 accelerometry and compared between intervention and control groups.
Change in Daily Step Count
Change from Baseline to Week 12 in average daily step count measured by the ActivPAL4 accelerometer and compared between intervention and control groups
Change in Self-Reported Sitting Time
Change from Baseline to Week 12 in self-reported sitting time (minutes/day) measured using the International Physical Activity Questionnaire (IPAQ) and compared between intervention and control groups.
Change in Body Mass Index (BMI)
Change from Baseline to Week 12 in body mass index (kg/m²) calculated from clinically obtained height and weight measurements.
Change in Waist Circumference
Change from Baseline to Week 12 in waist circumference (cm) measured by study staff.
Change in Blood Pressure
Change from Baseline to Week 12 in resting systolic and diastolic blood pressure obtained during routine clinical care.
Change in Resting Heart Rate
Change from Baseline to Week 12 in resting heart rate (beats per minute) obtained during routine clinical care.
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