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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-03

No results posted yet for this study

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)
  • Sedentary Behavior / Physical Inactivity
  • Cardiometabolic Health

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

Sponsors & Collaborators

Principal Investigators

  • Brittany Ivory, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-11-23
Completion
2028-12-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742891 on ClinicalTrials.gov