Effect of Nutrition Counseling and Physical Exercise Prescription on Body Composition and Nutritional Status of 5-18 Years Pediatric Cancer Patients on Treatment at Jimma Medical Center Pediatric Hematology and Oncology Unit(JMC-PHOU), Jimma, Ethiopia

NCT07558486 | Completed

• 2 other identifiers: Jimma UniversityJUIH/IRB/088/24
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition and associated muscle wasting are common health problems among pediatric cancer patients. However, the role of dietary counseling and physical exercise prescription intervention on both nutritional status and muscle health is not well documented in pediatric cancer patients, especially in those from low-and middle-income countries. This study will use quasi-experimental study design that will apply waiting list control and intervention groups to determine the effect of dietary counseling physical exercise prescription on the nutritional status and muscle wasting/sarcopenia among pediatric cancer patients in the age range of 5-18 years receiving cancer treatment at Jimma Medical Center Pediatric Hematology and Oncology Unit (JMC-PHOU). The study participants will be enrolled prospectively according their clinical visit. The participants will be categorized as intervention and awaiting list control groups. The intervention group received dietary counseling by using healthy eating plate as guide and motivational interview as counseling strategy for three consecutive months. In addition to dietary counseling the intervention group will receive three days per week, two sessions a day and 30 minutes per session aerobic(20 minutes per session) and resistance(10 minutes per session) physical exercise prescription. The waiting list control group will receive the same intervention three months later. The sample size was estimated by considering study power of and clinically significant effect size to 104 total sample sizes (i.e. 52 cases per each group). Data will be analyzed by paired sample t-test using IBM SPSS version 25. Statistical significance will be set at 5% with 95% confidence interval (CI). The study result will be reported in mean ±SD and t(df), p-value.

Conditions

Childhood Cancer

Keywords

Malnutrition; Body composition; sarcopenia; Pediatric/childhood cancer; dietary counseling; physical exercise prescription

Outcome Measures

Primary Outcomes (3)

• change body fat mass(FM) in kilogrames (Kg) by taking the difference of the measurments at the the start and end of intervention

  Body fat will be measured using bioelectrical impedance analysis(BIA)

  Three months

• Change in fat free mass(FFM) in kilograms (Kg)by taking the difference of the measurments at the the start and end of intervention

  Fat free mass will be measured using bioelectrical impedance analysis(BIA)

  three months

• Change in hydration staus by measuringby taking the difference of total body, extracelluar and intracellular water in liters(L) at the start and end of intervention

  Chnange in body hydration will be mesured using BIA

  three months

Study Arms (2)

Intervention

EXPERIMENTAL

dietary counseling and physical exercise prescription

Behavioral: dietary counseling and physical exercise prescription

Control arm

NO INTERVENTION

waiting list control group, will recive dietary counseling and physical exercise intervention three months later

Interventions

dietary counseling and physical exercise prescription BEHAVIORAL

This intervention is a combination of dietary counseling using healthy eating plate as a guide and motivational interviewing as a strategy and physical exercise prescription. To the knowledge of the investigator no such intervention was studied so far among pediatric cancer patients in low-and middle-income countries.

Intervention

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pediatric cancer patients of both sex and in the age range of 5 -18 years attending JMC
• Pediatric cancer patients who pass medical clerance for physical exercise Pediatric cancer pateitns who consent to participate in the study

You may not qualify if:

• Pediatric cancer patietnt lessthan five years
• Pediatric cancer patients with metallic device in their body for different treatment purposes like pacemaker, bone fracture support, artificial air way
• Pediatric cancer pateitns with severe medical problem and can't participate in physical exercise
• Pediatric cancer pateitns who/whose family decline the informed assent and consent

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Jimma Uniersity

Jimma, 378, Ethiopia

Location

MeSH Terms

Conditions

Neoplasms; Malnutrition; Sarcopenia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow in human nutrition

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 30, 2026
• Study Start: February 25, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

ET (1)