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| ID | Type | Description | Link |
|---|---|---|---|
| P30 CA 68485 OD | Other Grant/Funding Number | National Cancer Institute | |
| 2K12CA090625-11- A) | Other Identifier | RAC | |
| 2K12CA090625-11 | U.S. NIH Grant/Contract | View source | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (intervention) | Experimental | 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 (control) | No Intervention | Patients receive standard of care individualized diet and exercise plan |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional intervention | Dietary Supplement | Receive nutritional intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in number of pediatric ALL patients with BMI ≥ 75th percentile who agree to be randomized to participate in a lifestyle intervention program. | 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 | Baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 3 months and at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Esbenshade, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| exercise intervention |
| Behavioral |
Receive exercise intervention |
|
| follow-up care | Other | Receive booster follow-up sessions from the nutritionist and exercise physiologist |
|
| counseling intervention | Behavioral | Receive phone counseling with a trained health coach |
|
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| quality-of-life assessment | Other | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| questionnaire administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
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