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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

29 luglio 2026 aggiornato da: David Freyer, DO, MS, Children's Hospital Los Angeles

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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
Nessun intervento: Usual Care Control
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Total Sedentary Time
Lasso di tempo: 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.
Baseline and Week 12 (change from Baseline to Week 12).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Daily Sitting Time Measured by Accelerometry
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12)
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
Lasso di tempo: Up to Week 12.
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
Lasso di tempo: Throughout the 10-week intervention period.
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
Lasso di tempo: Week 12
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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Mass Index (BMI)
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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
Lasso di tempo: Baseline and Week 12 (change from Baseline to Week 12).
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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Children's Hospital Los Angeles

Investigatori

  • Investigatore principale: Brittany Ivory, MD, Children's Hospital Los Angeles

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

23 novembre 2028

Completamento dello studio (Stimato)

23 dicembre 2028

Date di iscrizione allo studio

Primo inviato

29 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2026

Primo Inserito (Effettivo)

3 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CHLA-26-00180

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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