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

NCT07742891 | Not Yet Recruiting

• 1 other identifier: CHLA-26-00180
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia (ALL); Cardiometabolic Health; Sedentary Behavior / Physical Inactivity

Keywords

Sedentary Behavior; Acute Lymphoblastic Leukemia (ALL); Mobile Health (mHealth) Intervention; Adolescents and Young Adults (AYA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

Other Outcomes (11)

• Change in Body Mass Index (BMI)

  Baseline and Week 12 (change from Baseline to Week 12).

• Change in Waist Circumference

  Baseline and Week 12 (change from Baseline to Week 12).

• Change in Blood Pressure

  Baseline and Week 12 (change from Baseline to Week 12).

Study Arms (2)

ReSeT2 Intervention

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

Interventions

ReSeT2 Intervention BEHAVIORAL

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

ReSeT2 Intervention

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Sedentary Behavior

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Brittany Ivory, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosy Romero

CONTACT

3233761067; roromero@chla.usc.edu

Brittany Ivory, MD

CONTACT

3233761067; bivory@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 23, 2028
• Study Completion (Estimated): December 23, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share