- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Jimma, 에티오피아, 378
- Jimma Uniersity
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Control arm
waiting list control group, will recive dietary counseling and physical exercise intervention three months later
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Jimma University (기타 보조금/기금 번호: Jimma University Institute of Health School Of Graduate Studies)
- JUIH/IRB/088/24 (기타 식별자: Jimma University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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