Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia

The Washington University

Status: Terminated

Conditions: Acute Lymphoblastic Leukemia

Treatments: Behavioral: Family-based Behavioral Weight Loss Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05410574

202205124

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Children: Family-based Behavioral Weight Loss Treatment (FBT)

Experimental group

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.

Treatment:

Behavioral: Family-based Behavioral Weight Loss Treatment

Caregivers: Family-based Behavioral Weight Loss Treatment (FBT)

Experimental group

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.

Treatment:

Behavioral: Family-based Behavioral Weight Loss Treatment