Weight Gain in Pediatric Leukemia Survivors

NCT07374315 | Not Yet Recruiting

• 1 other identifier: 202512147
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a trial assessing the efficacy of two weight maintenance programs for children with acute lymphoblastic leukemia (ALL) and the patients' caregivers. Patients and their caregivers will be randomized 1:1 to Arm A, a non-intensive educational intervention using National Institute of Health (NIH) Educational Resources (We Can! for children 8-13 and Take Charge of Your Health for teenagers 14-18), or Arm B, a Modified Guided Self-Help Family Intervention for Leukemia patients (mL-GSH). Outcomes will be assessed through activity trackers, obesity biometrics, and nutrition and physical activity assessments.

Conditions

Leukemia; Pediatric Acute Lymphoblastic Leukemia in Remission; Pediatric Obesity; Pediatric Acute Lymphoblastic Leukemia

Keywords

Leukemia; Lymphoblastic Leukemia; Weight Management; Late Effects; Health Behaviors; Healthy Habits

Outcome Measures

Primary Outcomes (7)

• Weight Z score

  Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from Center for Disease Control (CDC) growth Charts

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in weight Z score

  Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from CDC growth Charts. Changes in weight Z score from start to end of the study will be analyzed by changes in summary statistics (mean, median, and standard deviation) across timepoints.

  From start of study through end of study (estimated total time frame 12-15 months)

• BMI Z Score

  Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in BMI Z Score

  Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts. Changes in BMI Z score from start to end of the study will be analyzed by changes summary statistics (mean, median, and standard deviation) across timepoints.

  From start of study through end of study (estimated total time frame 12-15 months)

• Changes in Cholesterol

  Changes in cholesterol (total, LDL, and HDL levels) will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in HbA1c

  Changes in HbA1c will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in Albumin

  Changes in albumin will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

Secondary Outcomes (7)

• Changes in activity intensity assessed by Fitbit Ace Smartwatch using the Freedson age-adjusted equation

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in activity levels as measured by PAQ-C assessments

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in activity levels as measured by PAQ-A assessments

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in health behaviors as measured by the Health Behaviors Survey

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)

• Changes in 24-hour dietary recall as measured by ASA24

  Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention. Estimated total time frame of 12-15 months.

Study Arms (2)

Arm A: Educational Resources

ACTIVE COMPARATOR

Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.

Behavioral: NIH Educational Resources; Behavioral: FitBit Ace; Behavioral: WashU Extended Learning Canvas

Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)

EXPERIMENTAL

Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).

Behavioral: Modified Guided Self-Help Family Intervention; Behavioral: FitBit Ace; Behavioral: WashU Extended Learning Canvas

Interventions

Modified Guided Self-Help Family Intervention BEHAVIORAL

Patients and their caregivers will be led through mL-GSH in six sessions over the course of 6-9 months. Content is informed by priorities of caregivers and survivors of pediatric leukemia. The curriculum relies on participants identifying habits to monitor independently and supplementing their engagement with additional materials.

Also known as: mL-GSH

Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)

NIH Educational Resources BEHAVIORAL

Patients and their caregivers will be provided education materials from the NIH. The educational resources are We Can! a National Institute of Health educational resource designed for parents, caregivers, and communities to help children ages 8 through 13 improve their health and Take Charge of Your Health which is designed to provide education to teenagers to improve their health

Arm A: Educational Resources

FitBit Ace BEHAVIORAL

Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity.

Arm A: Educational Resources; Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)

WashU Extended Learning Canvas BEHAVIORAL

All caregivers will be provided access to WashU Extended Learning Canvas. The WashU Extended Learning Canvas will have an online support group for caregivers to engage in with other caregivers in the trial.

Arm A: Educational Resources; Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Patient Eligibility Criteria: * Must have a diagnosis of ALL (T or B cell). * Must be receiving standard of care maintenance chemotherapy or be within 6 months of having concluded maintenance chemotherapy at the time of enrollment. * Must be at least 6 years of age and no older than 18 years of age at time of enrollment. * Must be able to speak and understand English. * Must have a caregiver who is participating in this study. * Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report. * Must not have severe developmental delay/intellectual disabilities (such as Trisomy32, severe presentations of autism spectrum disorder) or significant mental illness (such as active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, or severe substance use disorder) that may interfere with ability to participate in modified Family Based Therapy (FBT). * Patients 10 and older must have a negative SCOFF screen for disordered eating (Score of 2 or more would disqualify the patient and require discussion with primary team) * Must be able to understand and willing to sign an IRB-approved written informed consent document or be able to provide verbal assent along with written consent provided by a legally authorized representative. Caregiver Eligibility Criteria: * Self-reported as the primary caregiver of a pediatric patient diagnosed with ALL who is also participating in this study. * Must be at least 18 years of age. * Must be able to speak and understand English. * Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report * Must be able to understand willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pediatric Obesity; Health Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Margaret Ferris, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Ferris, MD, PhD

CONTACT

314-454-6018; youngm@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Forty patient-caregiver dyads (total of 80 participants) will be enrolled and randomized 1:1 to Arm A or Arm B.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 28, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after publication of study results with no end date for data sharing.
• Access Criteria: Data will be shared with any individual who wishes to have access to the data for any purpose. Data will be included in supplementary materials of publication. Data will also be available by request to the corresponding authors of the publication.

Locations

US (1)