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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Lymphoblastic Leukemia (ALL); Cardiometabolic Health; Sedentary Behavior / Physical Inactivity
• Intervention / Treatment: Behavioral: ReSeT2 Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosy Romero; Phone Number: 3233761067; Email: roromero@chla.usc.edu
• Study Contact Backup: Name: Brittany Ivory, MD; Phone Number: 3233761067; Email: bivory@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReSeT2 Intervention; Participants receive the 10-week ReSeT2 multi-component mobile health intervention, including a Fitbit with inactivity prompts, home activity equipment, goal-based incentives, individualized coaching sessions, a GroupMe peer support chat, and optional in-person group sessions.	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
No Intervention: Usual Care Control; Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12 (change from Baseline to Week 12).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12 (change from Baseline to Week 12).
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.	Baseline and Week 12 (change from Baseline to Week 12).
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	Baseline and Week 12 (change from Baseline to Week 12).
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.	Baseline and Week 12 (change from Baseline to Week 12)
Study Retention Rate	Participant retention, defined as the proportion of enrolled participants who complete the Week 12 assessment. This feasibility measure will be summarized descriptively.	Up to Week 12.
Fitbit Wear Adherence	Intervention adherence measured by Fitbit wear time during the 10-week intervention period. A valid wear day is defined as at least 10 hours of wear during waking hours based on continuous heart rate data.	Throughout the 10-week intervention period.
Intervention Acceptability Survey Responses	Participant-reported acceptability of the ReSeT2 intervention assessed using a study-specific exit survey consisting of Likert-scale and open-ended questions evaluating satisfaction, perceived usefulness, and burden of intervention components.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Waist Circumference	Change from Baseline to Week 12 in waist circumference (cm) measured by study staff.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Blood Pressure	Change from Baseline to Week 12 in resting systolic and diastolic blood pressure obtained during routine clinical care.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Resting Heart Rate	Change from Baseline to Week 12 in resting heart rate (beats per minute) obtained during routine clinical care.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Hemoglobin A1c	Change from Baseline to Week 12 in hemoglobin A1c (HbA1c, %) as a measure of glucose metabolism	Baseline and Week 12 (change from Baseline to Week 12).
Change in Fructosamine	Change from Baseline to Week 12 in serum fructosamine concentration as a measure of short-term glucose control.	Baseline and Week 12 (change from Baseline to Week 12).
Change in High-Sensitivity C-Reactive Protein	Change from Baseline to Week 12 in high-sensitivity C-reactive protein (hs-CRP) concentration as a biomarker of systemic inflammation	Baseline and Week 12 (change from Baseline to Week 12).
Change in Lipid Profile	Change from Baseline to Week 12 in fasting lipid measures, including total cholesterol, high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), and triglycerides. This is an optional study procedure.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Health-Related Quality of Life	Change from Baseline to Week 12 in participant-reported Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale scores assessing physical, emotional, social, and school functioning.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Fatigue	Change from Baseline to Week 12 in Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale scores.	Baseline and Week 12 (change from Baseline to Week 12).
Change in Self-Efficacy	Change from Baseline to Week 12 in NIH Toolbox Self-Efficacy Questionnaire standardized scores, with higher scores indicating greater perceived self-efficacy.	Baseline and Week 12 (change from Baseline to Week 12).

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Brittany Ivory, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 23, 2028
• Study Completion (Estimated): December 23, 2028

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Sedentary Behavior; Acute Lymphoblastic Leukemia (ALL); Adolescents and Young Adults (AYA); Mobile Health (mHealth) Intervention
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Behavior; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sedentary Behavior
• Other Study ID Numbers: CHLA-26-00180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No