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LeukemiaNCT07374315

Weight Gain in Pediatric Leukemia Survivors

A study testing Modified Guided Self-Help Family Intervention, NIH Educational Resources and FitBit Ace in people with Leukemia and Pediatric Acute Lymphoblastic Leukemia, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
Modified Guided Self-Help Family Intervention, NIH Educational Resources and FitBit Ace
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
30 Nov 2026to 31 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Margaret Ferris, MD, PhD contact

314-454-6018

youngm@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Margaret Ferris, MD, PhD, 314-454-6018, youngm@wustl.edu

    Margaret Ferris, M.D., PhD

Other trials in United States

About this study

Official title: A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors

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.

Being tested
Modified Guided Self-Help Family Intervention, NIH Educational Resources, FitBit Ace, WashU Extended Learning Canvas
Keywords
Leukemia, Lymphoblastic Leukemia, Weight Management, Late Effects, Health Behaviors, Healthy Habits
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pediatric Obesity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Guided Self-Help Family InterventionBehavioural

    Also called mL-GSH

    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 ResourcesBehavioural

    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 AceBehavioural

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

  • WashU Extended Learning CanvasBehavioural

    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.

Study groups in NCT07374315
Study groupRoleWhat they receive
Arm A: Educational ResourcesActive comparatorParticipants 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.
Receives: Behavioral: NIH Educational Resources; Behavioral: FitBit Ace; Behavioral: WashU Extended Learning Canvas
Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)ExperimentalParticipants 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).
Receives: Behavioral: Modified Guided Self-Help Family Intervention; Behavioral: FitBit Ace; Behavioral: WashU Extended Learning Canvas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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)

  2. 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.

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

  3. 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

    Measured: 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)

  4. 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.

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

  5. 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.

    Measured: 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)

  6. Changes in HbA1c

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

    Measured: 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)

  7. Changes in Albumin

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

    Measured: 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)

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

    The Freedson age-adjusted equation is used to estimate maximum heart rate based on age and then is used to classify activity intensity by the heart rate of the activity.

    Measured: 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)

  2. Changes in activity levels as measured by PAQ-C assessments

    Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Older Children (PAQ-C). The PAQ-C is a self-administered, 7 day recall questionnaire designed to assess physical activity of children by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-C score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level.

    Measured: 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)

  3. Changes in activity levels as measured by PAQ-A assessments

    Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Adolescents (PAQ-A). The PAQ-A is a self-administered, 7 day recall questionnaire designed to assess physical activity of adolescents by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-A score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level.

    Measured: 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)

  4. Changes in health behaviors as measured by the Health Behaviors Survey

    The health behaviors survey assesses average daily activity level, screen time, sweetened beverage consumption, and fruit and vegetables consumption to determine if patients are compliant with American Academy of Pediatrics Recommendation. 44% of childhood cancer survivors are active more than 60 minutes a day, 40% engage in less than 1 hour of screen time, 34% consume sweetened beverages and 4% consume more than one serving of fruits and vegetables.

    Measured: 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)

  5. Changes in 24-hour dietary recall as measured by ASA24

    Patient and caregiver feeding habits will be assessed by their responses to a 24 hour dietary recall through the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). ASA24 is a web-based, automated dietary recall tool that uses images and prompts. The ASA24 produces automated nutrient and food group data on participant's diet, a Respondent Nutrition Report (RNR). The RNR data will be used to generate a Healthy Eating Index score ranging from 0-100 with higher scores indicating closer alignment to the Dietary Guidelines for Americans. Between group differences between Arm A and Arm B will be compared via various statistical methods.

    Measured: 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.

  6. Changes in health behaviors as measured by Childhood Feeding Questionnaire

    Changes in health behaviors will be assessed by caregivers' responses to the Child Feeding Questionnaire (CFQ and CFQ-teen) across different timepoints. The Child Feeding Questionnaire is a 31-item questionnaire using a 5-point Likert scale to assesses parents/caregivers' beliefs, attitudes, and practices surrounding feeding and their perceptions of their child's weight and eating behavior. The CFQ includes seven subscales. Subscales are scored from 1-5 with general guidelines for interpreting subscale scores as follows: 1.0-1.9 very low use of that feeding practice/low perception, 2.0-2.9 below average/mild expression, 3.0-3.9 moderate/typical parental level, and 4.0-5.0 high use or strong perception/belief.

    Measured: 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)

  7. Changes in Health Habits Survey

    Changes in answers to the Health Habits Survey will be assessed by caregivers and patients' responses to the survey at different timepoints. The Health Habits Survey is an assessment consisting of four questions evaluating health behaviors using 4-point Likert scales. These behaviors include daily activity level (not very often, <30 min a day, 30-60 min a day, and ≥ 60 min a day), screen time ( ≥2 hr a day, 1-2 hr a day, 30-60 min a day, and not very often), sweetened beverage consumption ( ≥3 a day, two a day, one a day, and not very often), and fruit and vegetable consumption (0-1, 1-2, 3-4, or >4 times a day.). The investigators will consider percentage of children whose health habits align with American Academy of Pediatric recommendations - 5 fruits and vegetables per day, 2 hours or less of screen time, 1 hour of physical activity, 0 sweetened beverages consumed.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Forty patient-caregiver dyads (total of 80 participants) will be enrolled and randomized 1:1 to Arm A or Arm B.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07374315
Sponsor's protocol ID
202512147
Status last verified
Oct 2026
First submitted
16 Jan 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data collected during the trial will be deidentified and accessible following publication of study results.

Questions about this trial

What is this clinical trial studying?

A study testing Modified Guided Self-Help Family Intervention, NIH Educational Resources and FitBit Ace in people with Leukemia and Pediatric Acute Lymphoblastic Leukemia, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Margaret Ferris, MD, PhD (314-454-6018, youngm@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Z score (time frame: 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07374315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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