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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 (JMC-PHOU)

23. april 2026 opdateret af: Asfaw Gerbi, Jimma University

Diet and Physical Exercise Intervention: Quasi Experimental Study

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Jimma, Etiopien, 378
        • Jimma Uniersity

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
dietary counseling and physical exercise prescription
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.
Ingen indgriben: Control arm
waiting list control group, will recive dietary counseling and physical exercise intervention three months later

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change body fat mass(FM) in kilogrames (Kg) by taking the difference of the measurments at the the start and end of intervention
Tidsramme: Three months
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
Tidsramme: three months
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
Tidsramme: three months
Chnange in body hydration will be mesured using BIA
three months

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. februar 2025

Primær færdiggørelse (Faktiske)

10. april 2026

Studieafslutning (Faktiske)

10. april 2026

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2026

Sidst verificeret

1. april 2026

Mere information

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