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NCT Number: NCT07558486

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Three months

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

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

    Time frame: three months

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

  3. 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

    Time frame: three months

    Chnange in body hydration will be mesured using BIA

Sponsors and collaborators

Lead sponsor

Jimma University

Other

Registry information

Official study title

Diet and Physical Exercise Intervention: Quasi Experimental Study

Acronym: JMC-PHOU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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