Jimma Uniersity
Jimma, 378, Ethiopia
NCT Number: NCT07558486
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.
Looking for future studies?
Notify Me5 year–18 year
All sexes
Interventional
Not applicable
Jimma, 378, Ethiopia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Three months
Body fat will be measured using bioelectrical impedance analysis(BIA)
Time frame: three months
Fat free mass will be measured using bioelectrical impedance analysis(BIA)
Time frame: three months
Chnange in body hydration will be mesured using BIA
Jimma University
Other
Diet and Physical Exercise Intervention: Quasi Experimental Study
Acronym: JMC-PHOU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT06036407
Chemically-Induced Disorders, Childhood Cancer
Bern, Switzerland
View Trial DetailsNCT04714840
Childhood Cancer, Mobility Limitation
Memphis, Tennessee, United States
View Trial DetailsNCT06205251
Cancer Survivors, Childhood Cancer
Baltimore, Maryland, United States
View Trial Details