Clinical trial

Weight Gain in Pediatric Leukemia Survivors

Opening soon · Not applicable · 1 countries · Registry ID NCT07374315

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionLeukemia, Pediatric Acute Lymphoblastic Leukemia, Pediatric Acute Lymphoblastic Leukemia in Remission, Pediatric Obesity

Full registry criteria

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.

Treatments and study arms

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.

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

FitBit Ace

Behavioral

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

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.

Primary outcomes

Weight Z scoreEnrollment, 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)

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

Changes in weight Z scoreFrom start of study through end of study (estimated total time frame 12-15 months)

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.

BMI Z ScoreEnrollment, 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)

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

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.

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

Changes in HbA1cEnrollment, 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 will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Washington University School of Medicine🇺🇸 St Louis, Missouri, United States
Margaret Ferris, MD, PhDContact
Margaret Ferris, M.D., PhDPrincipal Investigator
Mary Claire McGlynn, M.D.Sub Investigator