Acute Lymphoblastic LeukemiaNCT05410574
Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
A study testing Family-based Behavioral Weight Loss Treatment in people with Acute Lymphoblastic Leukemia, run by Washington University School of Medicine at 1 site in United States.
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.… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Family-based Behavioral Weight Loss Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2022to 26 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Family-based Behavioral Weight Loss Treatment
- Keywords
- Overweight/obesity, Weight management, Family based behavioral weight loss treatment (FBT)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based Behavioral Weight Loss TreatmentBehavioural
Also called FBT
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Family-based Behavioral Weight Loss Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At completion of intervention (estimated to be at 4 months)
Secondary outcomes (5)
Change in relative height (children only)
Measured: Baseline, end of intervention (at 4 months), 6 months, and 12 months
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.
Measured: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Change in relative weight
Measured: Baseline, end of intervention (at 4 months), 6 months, and 12 months
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.
Measured: 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)
-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
Measured: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start22 Jul 2022
- Primary completion31 Jul 2023
- Study completion26 Mar 2024
Why it stopped: Insufficient staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica J Jakubiak, MA, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410574
- Sponsor's protocol ID
- 202205124
- Status last verified
- May 2024
- First submitted
- 24 May 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38559896
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05410574
- Acronym / sponsor ID
- 202205124
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Overweight/obesity, Weight management, Family based behavioral weight loss treatment (FBT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient staff
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children: Family-based Behavioral Weight Loss Treatment (FBT) | Experimental | Behavioral: Family-based Behavioral Weight Loss Treatment* 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. |
| Caregivers: Family-based Behavioral Weight Loss Treatment (FBT) | Experimental | Behavioral: Family-based Behavioral Weight Loss Treatment* 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based Behavioral Weight Loss TreatmentAlso: FBTThe 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 | Behavioural | Caregivers: Family-based Behavioral Weight Loss Treatment (FBT), Children: Family-based Behavioral Weight Loss Treatment (FBT) |
Primary outcome
Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)
Time frame: At completion of intervention (estimated to be at 4 months)
-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)
Time frame: At completion of intervention (estimated to be at 4 months)
-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)
Time frame: At completion of intervention (estimated to be at 4 months)
-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)
Time frame: At completion of intervention (estimated to be at 4 months)
-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.
5 secondary outcomes
Change in relative height (children only)
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Change in dietary intake
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Change in relative weight
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Change in physical activity as measured by HBSC adaptation
Time frame: 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)
Time frame: Baseline, end of intervention (at 4 months), 6 months, and 12 months
Results and safety
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 38559896Jakubiak 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica J Jakubiak, MA principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based Behavioral Weight Loss Treatment in people with Acute Lymphoblastic Leukemia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM) (time frame: At completion of intervention (estimated to be at 4 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.