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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2024-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PACE-CALL: A Weight Control Intervention for Survivors of Childhood Leukemia

NCT01171599

Obesity Overweight Weight Loss +1 more

COMPLETED NA

A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

NCT04980118

Breast Cancer Body Weight Changes Weight Loss +1 more

COMPLETED NA

PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

NCT01253720

Acute Lymphoblastic Leukemia Cancer Obesity

COMPLETED NA

Stepped Care for Weight Loss Maintenance

NCT06151145

Obesity

RECRUITING NA

Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

NCT02487121

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

* 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.

Group Type EXPERIMENTAL

Family-based Behavioral Weight Loss Treatment

Intervention Type 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

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

* 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.

Group Type EXPERIMENTAL

Family-based Behavioral Weight Loss Treatment

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FBT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No