ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of being tired caused by cancer, may help improve strength, and may help build up lost muscle tissue. Nutritional intervention plus exercise intervention may be effective at preventing metabolic syndrome.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||March 2016 (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] >= 75th 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
|Contact: Clinical Trials Information Program||800-811-8480|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Clinical Trials Information Program 800-811-8480|
|Contact: Renee Ashworth (615) 322-3206|
|Principal Investigator:||Adam Esbenshade, MD||Vanderbilt-Ingram Cancer Center|