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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.

Patients receive standard of care individualized diet and exercise plan

nutritional intervention

exercise intervention

Receive booster follow-up sessions from the nutritionist and exercise physiologist

follow-up care

Receive phone counseling with a trained health coach

counseling intervention

quality-of-life assessment

laboratory biomarker analysis

questionnaire administration

Adam Esbenshade, MD

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.

PRIMARY OBJECTIVES:

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.

ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

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

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Assistant Professor, Pediatric Hematology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients	NCT01901367	Childhood Acute...	nutritional int... exercise interv... follow-up care counseling inte... quality-of-life... laboratory biom... questionnaire a...	2 Years - 18 Years	Vanderbilt-Ingram Cancer Center
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients	NCT01901367	Childhood Acute...	nutritional int... exercise interv... follow-up care counseling inte... quality-of-life... laboratory biom... questionnaire a...	2 Years - 18 Years	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for adiponectin, glucose, insulin, leptin