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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

2026年7月29日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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
介入なし：Usual Care Control
Participants continue standard clinical care and complete study assessments without receiving the ReSeT2 intervention.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Total Sedentary Time
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Daily Sitting Time Measured by Accelerometry
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Body Mass Index (BMI)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Children's Hospital Los Angeles

捜査官

  • 主任研究者：Brittany Ivory, MD、Children's Hospital Los Angeles

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年11月23日

研究の完了 (推定)

2028年12月23日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年7月29日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月3日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CHLA-26-00180

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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