ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
|Childhood Acute Lymphoblastic Leukemia in Remission||Dietary Supplement: nutritional intervention Behavioral: exercise intervention Other: follow-up care Behavioral: counseling intervention Other: quality-of-life assessment Other: laboratory biomarker analysis Other: questionnaire administration|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients|
- Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program. [ Time Frame: Baseline and at 6 months ]Patients undergo a nutrition and counseling intervention designed to decrease their calorie intake, meet micronutrient recommendations, and participate in an exercise plan. Feasibility is defined as >50% of patients who complete the intervention
- Percentage of increase or decrease in BMI of pediatric ALL patients with a BMI > 75th percentile who undergo a nutrition and counseling intervention compared to a control group of pediatric ALL patients who do not undergo intervention [ Time Frame: At 3 months and at 6 months ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||September 30, 2017|
|Primary Completion Date:||September 30, 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (intervention)
Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.
Dietary Supplement: nutritional intervention
Receive nutritional interventionBehavioral: exercise intervention
Receive exercise interventionOther: follow-up care
Receive booster follow-up sessions from the nutritionist and exercise physiologistBehavioral: counseling intervention
Receive phone counseling with a trained health coach
Other Name: counseling and communications studiesOther: quality-of-life assessment
Ancillary studiesOther: laboratory biomarker analysis
Correlative studiesOther: questionnaire administration
No Intervention: Arm II (control)
Patients receive standard of care individualized diet and exercise plan
I. To evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphoblastic leukemia (ALL) patients or those at high risk to become so (body mass index [BMI] >= 50th percentile).
II. Assess changes in BMI z-score, waist circumference, body composition, blood pressure exercise tolerance and physical activity at baseline, immediately post intervention and three months later.
III. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the intervention course and at 3 months post intervention.
IV. Assess changes in self-reported quality of life, physical activity, caloric intake, and fatigue associated with the nutrition and exercise program in the participant and their primary caregiver.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care individualized diet and exercise plan and monthly booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone counseling with a trained health coach to address barriers to improve plan adherence.
ARM II: Patients receive standard of care individualized diet and exercise plan.
After completion of study treatment, patients are followed up at 3 and 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01901367
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Adam Esbenshade, MD||Vanderbilt-Ingram Cancer Center|