Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Educational Resources | Active Comparator | 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. |
|
| Arm B: Modified Guided Self-Help Family Intervention (mL-GSH) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Guided Self-Help Family Intervention | Behavioral | Patients and their caregivers will be led through mL-GSH in six sessions over the course of 6-9 months. Content is informed by priorities of caregivers and survivors of pediatric leukemia. The curriculum relies on participants identifying habits to monitor independently and supplementing their engagement with additional materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Z score | 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 | 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 weight Z score | 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. | From start of study through end of study (estimated total time frame 12-15 months) |
| BMI Z Score | 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 | 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 BMI Z Score | 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. | From start of study through end of study (estimated total time frame 12-15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in activity intensity assessed by Fitbit Ace Smartwatch using the Freedson age-adjusted equation | The Freedson age-adjusted equation is used to estimate maximum heart rate based on age and then is used to classify activity intensity by the heart rate of the activity. | 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) |
Not provided
Patient Eligibility Criteria:
Caregiver Eligibility Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret Ferris, MD, PhD | Contact | 314-454-6018 | youngm@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Margaret Ferris, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
All individual participant data collected during the trial will be deidentified and accessible following publication of study results.
Data will be shared after publication of study results with no end date for data sharing.
Data will be shared with any individual who wishes to have access to the data for any purpose. Data will be included in supplementary materials of publication. Data will also be available by request to the corresponding authors of the publication.
Not provided
Not provided
Forty patient-caregiver dyads (total of 80 participants) will be enrolled and randomized 1:1 to Arm A or Arm B.
Not provided
Not provided
Not provided
Not provided
|
|
| NIH Educational Resources | Behavioral | Patients and their caregivers will be provided education materials from the NIH. The educational resources are We Can! a National Institute of Health educational resource designed for parents, caregivers, and communities to help children ages 8 through 13 improve their health and Take Charge of Your Health which is designed to provide education to teenagers to improve their health |
|
| FitBit Ace | Behavioral | Patients will be provided with a FitBit Ace. FitBit Ace will be worn by patients to track physical activity. |
|
| WashU Extended Learning Canvas | Behavioral | All caregivers will be provided access to WashU Extended Learning Canvas. The WashU Extended Learning Canvas will have an online support group for caregivers to engage in with other caregivers in the trial. |
|
| Changes in Cholesterol |
Changes in cholesterol (total, LDL, and HDL levels) will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints. |
| 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 | Changes in HbA1c will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints. | 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 | Changes in albumin will be analyzed via summary statistics (means, medians, and standard deviation) at each of the endpoints. | 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 | Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Older Children (PAQ-C). The PAQ-C is a self-administered, 7 day recall questionnaire designed to assess physical activity of children by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-C score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level. | 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 | Activity levels will be assessed by participants' changes in scores across different timepoints on Physical Activity Questionnaire for Adolescents (PAQ-A). The PAQ-A is a self-administered, 7 day recall questionnaire designed to assess physical activity of adolescents by proving a summary score of moderate to vigorous physical activity (MVPA). The mean PAQ-A score is interpreted as follows: 1.0-1.9 low physical activity, 2.0-2.9 moderate-low activity, 3.0-3.9 moderate activity, and 4.0-5.0 high activity. A higher score indicates a higher activity level. | 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 | The health behaviors survey assesses average daily activity level, screen time, sweetened beverage consumption, and fruit and vegetables consumption to determine if patients are compliant with American Academy of Pediatrics Recommendation. 44% of childhood cancer survivors are active more than 60 minutes a day, 40% engage in less than 1 hour of screen time, 34% consume sweetened beverages and 4% consume more than one serving of fruits and vegetables. | 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 | Patient and caregiver feeding habits will be assessed by their responses to a 24 hour dietary recall through the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). ASA24 is a web-based, automated dietary recall tool that uses images and prompts. The ASA24 produces automated nutrient and food group data on participant's diet, a Respondent Nutrition Report (RNR). The RNR data will be used to generate a Healthy Eating Index score ranging from 0-100 with higher scores indicating closer alignment to the Dietary Guidelines for Americans. Between group differences between Arm A and Arm B will be compared via various statistical methods. | 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 | Changes in health behaviors will be assessed by caregivers' responses to the Child Feeding Questionnaire (CFQ and CFQ-teen) across different timepoints. The Child Feeding Questionnaire is a 31-item questionnaire using a 5-point Likert scale to assesses parents/caregivers' beliefs, attitudes, and practices surrounding feeding and their perceptions of their child's weight and eating behavior. The CFQ includes seven subscales. Subscales are scored from 1-5 with general guidelines for interpreting subscale scores as follows: 1.0-1.9 very low use of that feeding practice/low perception, 2.0-2.9 below average/mild expression, 3.0-3.9 moderate/typical parental level, and 4.0-5.0 high use or strong perception/belief. | 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 | Changes in answers to the Health Habits Survey will be assessed by caregivers and patients' responses to the survey at different timepoints. The Health Habits Survey is an assessment consisting of four questions evaluating health behaviors using 4-point Likert scales. These behaviors include daily activity level (not very often, <30 min a day, 30-60 min a day, and ≥ 60 min a day), screen time ( ≥2 hr a day, 1-2 hr a day, 30-60 min a day, and not very often), sweetened beverage consumption ( ≥3 a day, two a day, one a day, and not very often), and fruit and vegetable consumption (0-1, 1-2, 3-4, or >4 times a day.). The investigators will consider percentage of children whose health habits align with American Academy of Pediatric recommendations - 5 fruits and vegetables per day, 2 hours or less of screen time, 1 hour of physical activity, 0 sweetened beverages consumed. | 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) |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D063766 | Pediatric Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided