Weight Management for Pediatric Leukemia Survivors
This study is looking at two different programs to help children who have had acute lymphoblastic leukemia (ALL) and their caregivers manage weight. You or your child might receive either educational materials from the National Institutes of Health (NIH) or a program called Modified Guided Self-Help Family Intervention (mL-GSH). The study is for children aged 6 to 18 who have been diagnosed with ALL and are currently receiving or recently finished maintenance chemotherapy. We want to see if these programs can help improve weight and body mass index (BMI) over about 12-15 months.
- Study design
- This is an interventional study with 80 participants. You and your caregiver will be randomly assigned to one of two groups.
- What's involved
- You will participate in six sessions over 6-9 months, and your weight and BMI will be measured at several points over 12-15 months. You will also wear a FitBit Ace to track physical activity.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your weight and BMI will be measured for up to 6 months after the intervention ends, for a total study time of 12-15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Weight Gain in Pediatric Leukemia Survivors
At a glance
Conditions
NCT07374315
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Margaret Ferris, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.