Clinical trial · Interventional
Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
NCT05410574CI-TRIAL-00076726terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient staff
Summary
Brief summary (as posted)
A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Family-based Behavioral Weight Loss Treatment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Children: Family-based Behavioral Weight Loss Treatment (FBT)
- description
- * 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.
- interventionNames
- Behavioral: Family-based Behavioral Weight Loss Treatment
- type
- EXPERIMENTAL
- label
- Caregivers: Family-based Behavioral Weight Loss Treatment (FBT)
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
Inclusion Criteria: * English-speaking caregiver-child dyads * Children must be between ages of 5-18 * Child must be overweight or obese (defined as a BMI greater than the 85th percentile for their age and sex) * Child must have been diagnosed with ALL * Child must have completed their final cancer treatment and currently be in remission * Only children and adolescents who have not yet graduated from high school and are living at home with their caregiver at least 50% of the time will be invited to enroll * Participating caregivers and children must be able to perform some level of exercise Exclusion Criteria: * Children who are wards of the state * Caregivers and/or children who are taking a weight altering medication without being at current dosage for at least six months and weight stable for at least three months * Caregivers and/or children who are actively involved in another intensive weight loss program * Caregivers and/or children who have undergone weight loss surgery within the last two years and/or who are still losing weight * Caregivers and/or children with certain diagnosed psychiatric conditions (e.g., history of/active eating disorder, developmental delays/intellectual disabilities such as Down's syndrome and severe presentations of autism spectrum disorder, active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, severe substance use disorder) that would interfere with their ability to participate * Caregivers and/or children with certain chronic medical conditions (e.g., type 1 diabetes, muscular dystrophy) for whom participation may be contraindicated
References
Publications (1)
- DERIVEDJakubiak J, Guan M, Khan S, Fowler LA, Bates CR, King AA, Hayashi RJ, Fitzsimmons-Craft E, Wilfley DE. Adaptation of Family-Based Healthy Weight Program for Children who Survived Leukemia. Clin Pract Pediatr Psychol. 2024 Mar;12(1):93-103. doi: 10.1037/cpp0000495. Epub 2023 Oct 5. PMID 38559896