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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02456 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2010-0654 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.
PRIMARY OBJECTIVES:
I. To evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
SECONDARY OBJECTIVES:
I. To conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods.
II. To conduct qualitative research on exercise habits and willingness to engage in moderate walking.
III. To assess receptivity to electronic dietary and physical activity (PA) interventions in pediatric cancer patients and survivors (PCPSs) and their parents.
IV. To determine if nutrition interventions will prevent an increase in body mass index (BMI) from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.
V. To determine if a nutrition counseling intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin A1C and improve absolute lymphocyte counts (ALC) from baseline measurements for pediatric leukemia or lymphoma patients, receiving prednisone and/or dexamethasone therapy.
VI. To evaluate caloric intake, nutritional parameters and oxidative stress in pediatric leukemia or lymphoma patients receiving prednisone and/or dexamethasone therapy.
VII. To evaluate responses to various energy balance interventions.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.
ARM II: Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (counseling) | Active Comparator | Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts. |
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| Arm II (nutrition and PA intervention) | Experimental | Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Attend nutrition counseling sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Will assess the difference in waist circumferences between patients in the Arm 1 intervention group compared to patients in the Arm 1 control group. The primary analysis will use the two-sample t-tests, and will be conducted on the intent-to-treat basis. This implies that if patients in the control arm received nutrition counseling, that patient will still be labeled as control. | through study completion an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joya Chandra | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center website | View source |
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| Exercise Intervention | Behavioral | Complete PA sessions |
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| Informational Intervention | Other | Receive nutrition handouts |
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| Nutritional Intervention | Dietary Supplement | Attend tasting sessions |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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