Nutrition and Physical Activity Intervention in Preventing Excess Weight Gain in Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-12

Study Completion Date

2025-07-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (counseling)

Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.

Group Type ACTIVE_COMPARATOR

Counseling

Intervention Type OTHER

Attend nutrition counseling sessions

Informational Intervention

Intervention Type OTHER

Receive nutrition handouts

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (nutrition and PA intervention)

Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Complete PA sessions

Nutritional Intervention

Intervention Type DIETARY_SUPPLEMENT

Attend tasting sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Counseling

Attend nutrition counseling sessions

Intervention Type OTHER

Exercise Intervention

Complete PA sessions

Intervention Type BEHAVIORAL

Informational Intervention

Receive nutrition handouts

Intervention Type OTHER

Nutritional Intervention

Attend tasting sessions

Intervention Type DIETARY_SUPPLEMENT

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Counseling Intervention

Eligibility Criteria

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Inclusion Criteria

* Leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital
* Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital at time of enrollment
* Karnofsky performance status greater than or equal to 70
* Must be cleared by treating oncologist to participate in study
* Must live close enough to attend measurement sessions at one of the clinical centers

Exclusion Criteria

* Patients receiving nutrition counseling or weight management counseling elsewhere
* Pediatric patients who are already receiving steroids that are not part of treatment
* History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No