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Behavioral Intervention
Family-Based Behavioral Treatment for Childhood Leukemia
N/A
Waitlist Available
Led By Jessica J Jakubiak, MA
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child must have completed their final cancer treatment and currently be in remission
Child must have been diagnosed with ALL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of intervention (at 4 months), 6 months, and 12 months
Awards & highlights
Study Summary
This trial will study how well a weight loss intervention works for children with leukemia and their families.
Who is the study for?
This trial is for children aged 5-18 who are overweight or obese, have been diagnosed with acute lymphoblastic leukemia (ALL), and are now in remission. They must live at home with a caregiver more than half the time, not be taking weight-altering meds unless stable for six months, and can't be in another weight loss program or have had weight loss surgery within two years.Check my eligibility
What is being tested?
The study tests a family-based behavioral weight loss treatment over four months to see if it's acceptable and effective. It involves childhood ALL survivors and their families, focusing on relative weight change and health behaviors.See study design
What are the potential side effects?
Since this is a behavioral intervention focused on lifestyle changes rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort related to new exercise routines or dietary changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has finished cancer treatment and is now in remission.
Select...
My child has been diagnosed with Acute Lymphoblastic Leukemia (ALL).
Select...
My child's BMI is above the 85th percentile for their age and sex.
Select...
I am a student living with my caregiver more than half the time.
Select...
I am between 5 and 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at completion of intervention (estimated to be at 4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at completion of intervention (estimated to be at 4 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)
Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8)
Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)
+1 moreSecondary outcome measures
Change in dietary intake
Change in physical activity as measured by HBSC adaptation
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Children: Family-based Behavioral Weight Loss Treatment (FBT)Experimental Treatment1 Intervention
Traffic Light Eating Plan: All foods are assigned a color of the traffic light depending on their energy density & nutritional quality. Participants are encouraged to set dietary goals to decrease the number of RED food servings consumed daily & to increase the consumption of GREEN & YELLOW foods.
Traffic Light Activity Plan: Activities are assigned colors of the traffic light depending on intensity levels. Families are encouraged to increase time spent in GREEN activities and decreased RED activities.
Behavior Change Strategies: Behavior modification will be fostered using several different strategies
Social Facilitation: FBT emphasizes creating an ecology that supports long-term change, which includes modifying the family environment, reshaping peer networks, & ensuring that there are community resources available to maintain change.
Group II: Caregivers: Family-based Behavioral Weight Loss Treatment (FBT)Experimental Treatment1 Intervention
Traffic Light Eating Plan: All foods are assigned a color of the traffic light depending on their energy density & nutritional quality. Participants are encouraged to set dietary goals to decrease the number of RED food servings consumed daily & to increase the consumption of GREEN & YELLOW foods.
Traffic Light Activity Plan: Activities are assigned colors of the traffic light depending on intensity levels. Families are encouraged to increase time spent in GREEN activities and decrease RED activities.
Behavior Change Strategies: Behavior modification will be fostered using several different strategies
Social Facilitation: FBT emphasizes creating an ecology that supports long-term change, which includes modifying the family environment, reshaping peer networks, & ensuring that there are community resources available to maintain change.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,692 Total Patients Enrolled
Jessica J Jakubiak, MAPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic condition like type 1 diabetes or muscular dystrophy that may prevent me from participating.I or my child had weight loss surgery in the last 2 years and/or are still losing weight.I or my child do not have severe psychiatric or developmental conditions that would prevent participation.I have been on a stable dose of a weight-altering medication for at least 6 months and my weight has been stable for 3 months.I am a child under the care of the state.My child has finished cancer treatment and is now in remission.My child has been diagnosed with Acute Lymphoblastic Leukemia (ALL).My child's BMI is above the 85th percentile for their age and sex.I am a student living with my caregiver more than half the time.My child and I both speak English.I am between 5 and 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Children: Family-based Behavioral Weight Loss Treatment (FBT)
- Group 2: Caregivers: Family-based Behavioral Weight Loss Treatment (FBT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the participant pool growing for this research study?
"Affirmative. Clinicaltrials.gov has verified that this medical experiment, which was first posted on July 22nd 2022, is currently looking for recruits. In total, 80 individuals need to be signed up from 1 clinical site."
Answered by AI
Is there still capacity for this medical trial to accept new participants?
"According to the official records on ClinicalTrials.gov, this experiment is currently searching for participants. The trial was originally posted on July 22nd 2022 and had a recent edit made at the end of July 27th 2022."
Answered by AI
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