A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in HbA1c
研究概览
简要总结
This is a trial assessing the efficacy of two weight maintenance programs for children with acute lymphoblastic leukemia (ALL) and the patients' caregivers. Patients and their caregivers will be randomized 1:1 to Arm A, a non-intensive educational intervention using National Institute of Health (NIH) Educational Resources (We Can! for children 8-13 and Take Charge of Your Health for teenagers 14-18), or Arm B, a Modified Guided Self-Help Family Intervention for Leukemia patients (mL-GSH). Outcomes will be assessed through activity trackers, obesity biometrics, and nutrition and physical activity assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility Criteria:
- •Must have a diagnosis of ALL (T or B cell).
- •Must be receiving standard of care maintenance chemotherapy or be within 6 months of having concluded maintenance chemotherapy at the time of enrollment.
- •Must be at least 6 years of age and no older than 18 years of age at time of enrollment.
- •Must be able to speak and understand English.
- •Must have a caregiver who is participating in this study.
- •Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report.
- •Must not have severe developmental delay/intellectual disabilities (such as Trisomy32, severe presentations of autism spectrum disorder) or significant mental illness (such as active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, or severe substance use disorder) that may interfere with ability to participate in modified Family Based Therapy (FBT).
- •Patients 10 and older must have a negative SCOFF screen for disordered eating (Score of 2 or more would disqualify the patient and require discussion with primary team)
- •Must be able to understand and willing to sign an IRB-approved written informed consent document or be able to provide verbal assent along with written consent provided by a legally authorized representative.
- •Caregiver Eligibility Criteria:
- •Self-reported as the primary caregiver of a pediatric patient diagnosed with ALL who is also participating in this study.
- •Must be at least 18 years of age.
- •Must be able to speak and understand English.
- •Must be able to perform some level of exercise (e.g., a brisk walk for at least five minutes) as determined by self-report
- •Must be able to understand willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
排除标准
- 未提供
研究组 & 干预措施
Arm A: Educational Resources
Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.
干预措施: FitBit Ace (Behavioral)
Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)
Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).
干预措施: FitBit Ace (Behavioral)
Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)
Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).
干预措施: Modified Guided Self-Help Family Intervention (Behavioral)
Arm B: Modified Guided Self-Help Family Intervention (mL-GSH)
Participants will complete the Modified Guided Self-Help Family Intervention for survivors of leukemia (mL-GSH). ML-GSH is a six-session intervention to be delivered during appointments. Patients will have 6 months to complete the curriculum (may be up to 9 months to account for scheduling concerns).
干预措施: WashU Extended Learning Canvas (Behavioral)
Arm A: Educational Resources
Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.
干预措施: NIH Educational Resources (Behavioral)
Arm A: Educational Resources
Participants will be provided direction to NIH educational resources over the course of the intervention. Both programs provide resources to improve nutrition, increase physical activity, limit screen time, and improve sleep and consist of online, free, assessable educational materials. Patients and caregivers will be reminded of this resource at their monthly clinic appointments for 6 months after their first study visit.
干预措施: WashU Extended Learning Canvas (Behavioral)
结局指标
主要结局
Changes in HbA1c
时间窗: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)
Changes in HbA1c will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
Weight Z score
时间窗: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)
Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from Center for Disease Control (CDC) growth Charts
Changes in weight Z score
时间窗: From start of study through end of study (estimated total time frame 12-15 months)
Participant's weight Z score is a statistical value that indicates how the participant's weight for their age and sex compares to the average weight for that population which is obtained from CDC growth Charts. Changes in weight Z score from start to end of the study will be analyzed by changes in summary statistics (mean, median, and standard deviation) across timepoints.
BMI Z Score
时间窗: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)
Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts
Changes in BMI Z Score
时间窗: From start of study through end of study (estimated total time frame 12-15 months)
Participant's BMI Z score is a statistical value that indicates how the participant's BMI for their age and sex compares to the average BMI for that population which is obtained from CDC growth Charts. Changes in BMI Z score from start to end of the study will be analyzed by changes summary statistics (mean, median, and standard deviation) across timepoints.
Changes in Cholesterol
时间窗: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)
Changes in cholesterol (total, LDL, and HDL levels) will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
Changes in Albumin
时间窗: Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months)
Changes in albumin will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints.
次要结局
- Changes in activity intensity assessed by Fitbit Ace Smartwatch using the Freedson age-adjusted equation(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))
- Changes in activity levels as measured by PAQ-C assessments(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))
- Changes in Health Habits Survey(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))
- Changes in activity levels as measured by PAQ-A assessments(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))
- Changes in health behaviors as measured by the Health Behaviors Survey(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))
- Changes in 24-hour dietary recall as measured by ASA24(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention. Estimated total time frame of 12-15 months.)
- Changes in health behaviors as measured by Childhood Feeding Questionnaire(Enrollment, during intervention (4 months after enrollment), end of intervention (6 months after enrollment (may be up to 9 months)), and 6 months after end of intervention (estimated total time frame of 12-15 months))