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

NCT05410574 | Terminated

• 1 other identifier: 202205124
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Overweight/obesity; Weight management; Family based behavioral weight loss treatment (FBT)

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Change in relative height (children only)

  Baseline, end of intervention (at 4 months), 6 months, and 12 months

• Change in dietary intake

  Baseline, end of intervention (at 4 months), 6 months, and 12 months

• Change in relative weight

  Baseline, end of intervention (at 4 months), 6 months, and 12 months

• Change in physical activity as measured by HBSC adaptation

  Baseline, end of intervention (at 4 months), 6 months, and 12 months

• Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)

  Baseline, end of intervention (at 4 months), 6 months, and 12 months

Study Arms (2)

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

EXPERIMENTAL

* 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.

Behavioral: Family-based Behavioral Weight Loss Treatment

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

EXPERIMENTAL

* 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.

Behavioral: Family-based Behavioral Weight Loss Treatment

Interventions

Family-based Behavioral Weight Loss Treatment BEHAVIORAL

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

Also known as: FBT

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Jakubiak 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 DERIVED

Related Links

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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Overweight; Obesity

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica J Jakubiak, MA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 8, 2022
• Study Start: July 22, 2022
• Primary Completion: July 31, 2023
• Study Completion: March 26, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)