- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 (JMC-PHOU)
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
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Jimma, Etiopien, 378
- Jimma Uniersity
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
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
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 |
|---|---|
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Eksperimentel: Intervention
dietary counseling and physical exercise prescription
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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.
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Ingen indgriben: Control arm
waiting list control group, will recive dietary counseling and physical exercise intervention three months later
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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Body fat will be measured using bioelectrical impedance analysis(BIA)
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Three months
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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
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Fat free mass will be measured using bioelectrical impedance analysis(BIA)
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three months
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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
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Chnange in body hydration will be mesured using BIA
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three months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Ernæringsforstyrrelser
- Patologiske Tilstande, Anatomiske
- Muskelatrofi
- Atrofi
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fejlernæring
- Neoplasmer
- Sarkopeni
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Epidemiologiske målinger
- Ernæringsvurdering
Andre undersøgelses-id-numre
- Jimma University (Andet bevillings-/finansieringsnummer: Jimma University Institute of Health School Of Graduate Studies)
- JUIH/IRB/088/24 (Anden identifikator: Jimma University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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