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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change in Total Sedentary Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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.
结局指标
主要结局
Change in Total Sedentary Time
时间窗: Baseline and Week 12 (change from Baseline to Week 12).
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.
次要结局
- Change in Daily Sitting Time Measured by Accelerometry(Baseline and Week 12 (change from Baseline to Week 12).)
- Change in Time Spent in Prolonged Sedentary Bouts(Baseline and Week 12 (change from Baseline to Week 12).)
- Change in Daily Step Count(Baseline and Week 12 (change from Baseline to Week 12).)
- Change in Self-Reported Sitting Time(Baseline and Week 12 (change from Baseline to Week 12))
- Study Retention Rate(Up to Week 12.)
- Fitbit Wear Adherence(Throughout the 10-week intervention period.)
- Intervention Acceptability Survey Responses(Week 12)
研究者
David Freyer, DO, MS
Medical Staff/USC Faculty
Children's Hospital Los Angeles