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

NCT05049785 | Completed Early Phase 1

• 2 other identifiers: 2010-0654NCI-2019-02456
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I (counseling)

ACTIVE COMPARATOR

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

Other: Counseling; Other: Informational Intervention; Other: Questionnaire Administration

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.

Behavioral: Exercise Intervention; Dietary Supplement: Nutritional Intervention; Other: Questionnaire Administration

Interventions

Counseling OTHER

Attend nutrition counseling sessions

Also known as: Counseling Intervention

Arm I (counseling)

Exercise Intervention BEHAVIORAL

Complete PA sessions

Arm II (nutrition and PA intervention)

Informational Intervention OTHER

Receive nutrition handouts

Arm I (counseling)

Nutritional Intervention DIETARY_SUPPLEMENT

Attend tasting sessions

Arm II (nutrition and PA intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm I (counseling); Arm II (nutrition and PA intervention)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Lymphoma

Interventions

Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joya Chandra

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: May 12, 2011
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)