ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01901367|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2013
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 30, 2014|
|Estimated Study Completion Date :||February 2018|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901367
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Adam Esbenshade, MD||Vanderbilt-Ingram Cancer Center|