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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05410574
• Other study ID #: 202205124
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2022
• Est. completion date: March 26, 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 26, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Family-based Behavioral Weight Loss Treatment
The treatment includes: 1) the Traffic Light Eating Plan; 2) the Traffic Light Activity Program, 3) a variety of behavioral change strategies e.g., stimulus control, self-monitoring, planning, goal setting and 4) facilitation of support in the family and peer environments to optimize the durability and generalizability of health habits across multiple social and environmental contexts

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)	-4 questions about acceptability of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher acceptability of the intervention measure.	At completion of intervention (estimated to be at 4 months)
Primary	Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)	-4 questions about appropriateness of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher appropriateness of the intervention measure.	At completion of intervention (estimated to be at 4 months)
Primary	Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8)	-8 questions asking about satisfaction of intervention. The CSQ-8 offers four response options for each item (1-4) and an overall score is calculated by summing the respondent's rating score for each item. Scores range from 8-32 with higher scores indicating higher satisfaction.	At completion of intervention (estimated to be at 4 months)
Primary	Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM)	-4 questions about feasibility of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher feasibility of the intervention measure.	At completion of intervention (estimated to be at 4 months)
Secondary	Change in relative height (children only)		Baseline, end of intervention (at 4 months), 6 months, and 12 months
Secondary	Change in dietary intake	-Two assisted 24-hour dietary recalls encompassing one weekday and one weekend day and guided by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) will be completed for each participant. This data will be used to measure dietary quality according to the Healthy Eating Index (HEI). The HEI includes a total score as well as sub scores for items such as total fruit intake, whole fruit intake, and total vegetable intake. Total score and sub-scores will be presented.	Baseline, end of intervention (at 4 months), 6 months, and 12 months
Secondary	Change in relative weight		Baseline, end of intervention (at 4 months), 6 months, and 12 months
Secondary	Change in physical activity as measured by HBSC adaptation	-Self- (for children 10+ years) and parent-reported physical activity behavior will be collected via an adapted version of the Health Behavior in School Age Children survey. This three-question survey assesses the amount of time spent on moderate to vigorous physical activity and sedentary behaviors.	Baseline, end of intervention (at 4 months), 6 months, and 12 months
Secondary	Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)	-The IPAQ measures duration and frequency of activity over the past seven days. An overall score can be calculated, as well as sub-scores for moderate- and vigorous-intensity activity	Baseline, end of intervention (at 4 months), 6 months, and 12 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine