Clinical trial NCT05410574: Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
Official title: Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Overweight/obesity
Weight management
Family based behavioral weight loss treatment (FBT)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)
timeFrame: At completion of intervention (estimated to be at 4 months)
measure: Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)
timeFrame: At completion of intervention (estimated to be at 4 months)
measure: Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At completion of intervention (estimated to be at 4 months)
measure: Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM)
timeFrame: At completion of intervention (estimated to be at 4 months)
Secondary outcomes:
measure: Change in relative height (children only)
timeFrame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
measure: Change in dietary intake
timeFrame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
measure: Change in relative weight
timeFrame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
measure: Change in physical activity as measured by HBSC adaptation
timeFrame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
measure: Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)
timeFrame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jessica J Jakubiak, MA
role: PRINCIPAL_INVESTIGATOR
References: