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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based Behavioral Weight Loss Treatment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphoblastic Leukemia focused on measuring Overweight/obesity, Weight management, Family based behavioral weight loss treatment (FBT)

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 be at least 6 months post final cancer treatment and currently 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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Change in relative height (children only)
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.
Change in relative weight
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.
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

Full Information

First Posted
May 24, 2022
Last Updated
January 17, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05410574
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Overweight/obesity, Weight management, Family based behavioral weight loss treatment (FBT)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children: Family-based Behavioral Weight Loss Treatment (FBT)
Arm Type
Experimental
Arm 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.
Arm Title
Caregivers: Family-based Behavioral Weight Loss Treatment (FBT)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family-based Behavioral Weight Loss Treatment
Other Intervention Name(s)
FBT
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)
Description
-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.
Time Frame
At completion of intervention (estimated to be at 4 months)
Title
Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)
Description
-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.
Time Frame
At completion of intervention (estimated to be at 4 months)
Title
Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8)
Description
-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.
Time Frame
At completion of intervention (estimated to be at 4 months)
Title
Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM)
Description
-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.
Time Frame
At completion of intervention (estimated to be at 4 months)
Secondary Outcome Measure Information:
Title
Change in relative height (children only)
Time Frame
Baseline, end of intervention (at 4 months), 6 months, and 12 months
Title
Change in dietary intake
Description
-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.
Time Frame
Baseline, end of intervention (at 4 months), 6 months, and 12 months
Title
Change in relative weight
Time Frame
Baseline, end of intervention (at 4 months), 6 months, and 12 months
Title
Change in physical activity as measured by HBSC adaptation
Description
-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.
Time Frame
Baseline, end of intervention (at 4 months), 6 months, and 12 months
Title
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)
Description
-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
Time Frame
Baseline, end of intervention (at 4 months), 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica J Jackubiak, MA
Phone
314-273-1982
Email
jjakubiak@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica J Jakubiak, MA
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica J Jakubiak, MA
Phone
314-273-1982
Email
jjakubiak@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jessica J Jakubiak, MA
First Name & Middle Initial & Last Name & Degree
Robert Hayashi, M.D.
First Name & Middle Initial & Last Name & Degree
Allison King, M.D., M.P.H., Ph.D.
First Name & Middle Initial & Last Name & Degree
Denise Wilfley, Ph.D.
First Name & Middle Initial & Last Name & Degree
Robinson Welch, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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