ReSeT in ALL 2: A Randomized, Controlled Pilot Trial Testing an Optimized, Multi-component Mobile Health Intervention to Reduce Sedentary Time in Early Adolescents and Young Adults (eAYAs) With ALL During Maintenance Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReSeT2 Intervention.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia (ALL), Sedentary Behavior / Physical Inactivity, Cardiometabolic Health. Basic parameters: 13 years — 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral ReSeT2 Intervention
A 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
Primary outcome measures
- Change in Total Sedentary Time [Time frame: Baseline and Week 12 (change from Baseline to Week 12).]
Secondary outcome measures (7)
- Change in Daily Sitting Time Measured by Accelerometry [Time frame: Baseline and Week 12 (change from Baseline to Week 12).]
- Change in Time Spent in Prolonged Sedentary Bouts [Time frame: Baseline and Week 12 (change from Baseline to Week 12).]
- Change in Daily Step Count [Time frame: Baseline and Week 12 (change from Baseline to Week 12).]
- Change in Self-Reported Sitting Time [Time frame: Baseline and Week 12 (change from Baseline to Week 12)]
- Study Retention Rate [Time frame: Up to Week 12.]
- Fitbit Wear Adherence [Time frame: Throughout the 10-week intervention period.]
- Intervention Acceptability Survey Responses [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- 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.
- Patients receiving nelarabine-containing maintenance cycles are eligible.
- Self-reported sedentary lifestyle with an average of 4 or more leisure-time hours per day spent sedentary.
- Willing to reduce sedentary time.
- Parent/legal guardian available for consent (if applicable) and participant available for assent/consent as applicable.
- Access to the internet and a smartphone compatible with Fitbit and GroupMe (participant's or parent/guardian's device).
- Ability to participate in virtual sessions with study staff.
- Fluent in English. (Parents/guardians do not need to be English-speaking if consent can be completed in their primary language.)
Exclusion criteria
- 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.
- Unable to obtain study laboratory tests
- Unable to independently complete quality-of-life surveys accurately.
- Unable to complete study-related surveys.
- Pregnancy.
- Current imprisonment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07742891 · CHLA-26-00180