- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07583667
Nutrition Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
Nutritional Status, Associated Factors, and Preliminary Effectiveness of a Nutrition Health Education Intervention Among Ethnic Minority Children Aged 5-16 Years in Tra Vinh Province, Vietnam
The goal of this study is to evaluate the effectiveness of a nutrition health education intervention among ethnic minority children aged 5-16 years in Tra Vinh Province, Vietnam. It will also assess factors associated with nutritional status in this population.
The main questions it aims to answer are:
Does the nutrition health education intervention improve nutritional status? Does the intervention improve nutrition-related knowledge, attitudes, and practices (KAP)? Does the intervention improve diet quality and physical activity levels among participants?
Researchers will compare participants receiving the nutrition education intervention with control group to evaluate the effectiveness of the intervention.
Participants in intervention group will:
Participate in a structured nutrition education program delivered monthly for 4 months through interactive lessons, videos, and educational materials Receive ongoing support and reinforcement activities for an additional 2 months Attend baseline and follow-up assessments including anthropometric measurements and interviews Complete questionnaires on nutrition knowledge, dietary practices, and physical activity
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tra Vinh
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Thanh pho Tra Vinh, Tra Vinh, 베트남
- Community Health Centers in Tra Vinh Province
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Ethnic minority children aged 5-16 years
- Living in selected communities or attending selected schools
- Consent from parents/caregivers and assent from children
Exclusion Criteria:
- Congenital deformities affecting anthropometry
- Medical conditions affecting body composition measurement
- Inability to participate in interviews
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: intervention group
Participants receive a structured nutrition health education intervention delivered through community-based and school-based models.
The program includes four monthly educational sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries.
The intervention is implemented over four months, followed by a two-month maintenance phase with reinforcement activities involving community health workers, school staff, and family engagement.
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A multi-component nutrition health education program delivered through community-based and school-based models.
For children aged 5-10 years, both children and their caregivers participate in nutrition education sessions at local health stations.
For children aged 11-16 years, the intervention is delivered at ethnic minority boarding schools.
The program consists of four monthly structured sessions using presentations and videos, supported by interactive posters, nutrition leaflets, and dietary and physical activity diaries.
The key topics include: (1) nutrients and health, (2) prevention of undernutrition and overweight/obesity, (3) healthy dietary habits, and (4) physical activity promotion.
The intervention lasts four months, followed by a two-month maintenance phase with reinforcement by community health workers, school staff, and family engagement.
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간섭 없음: control group
Participants do not receive the structured nutrition education intervention.
They continue to receive routine health and nutrition education activities available at local community health centers and schools without additional intervention from the study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in BMI-for-age z-score
기간: Baseline and 6 months
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Weight and height will be combined to report BMI in kilogram/meters^2.
BMI-for-age z-score calculated according to the 2007 WHO growth standards.
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Baseline and 6 months
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Change in prevalence of malnutrition (including undernutrition and overweight/obesity)
기간: Baseline and 6 months
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Proportion of participants with abnormal nutritional status, including undernutrition (stunting, underweight, or thinness) and overweight/obesity, classified according to WHO growth reference standards based on age- and sex-specific z-scores.
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Baseline and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in nutrition-related knowledge, attitudes, and practices (KAP)
기간: Baseline and 6 months
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Nutrition knowledge, attitudes, and practices assessed using a structured questionnaire developed based on the Food and Agriculture Organization of the United Nations Guidelines for assessing nutrition-related knowledge, attitudes and practices. Knowledge scores ranged from 0 to 11, attitude scores from 0 to 17, and practice scores from 0 to 8, with higher scores indicating better nutrition knowledge, more favorable nutrition attitudes, and better nutrition practices. |
Baseline and 6 months
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Change in diet quality scores
기간: Baseline and 6 months
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Diet quality was assessed using the Diet Quality Questionnaire (DQQ), including the Dietary Diversity Score (DDS) and the Global Dietary Recommendations (GDR) score. The Dietary Diversity Score (DDS) ranges from 0 to 10 based on the number of food groups consumed, with higher scores indicating greater dietary diversity. The Global Dietary Recommendations (GDR) score ranges from 0 to 18 and reflects adherence to global dietary recommendations for protection against non-communicable diseases, with higher scores indicating better adherence to recommended dietary patterns. |
Baseline and 6 months
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Change in physical activity levels
기간: Baseline and 6 months
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Physical activity levels assessed using a standardized questionnaire, including frequency and duration of moderate-to-vigorous physical activity.
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Baseline and 6 months
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Change in skeletal muscle mass
기간: Baseline and 6 months
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Skeletal muscle mass (SMM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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Change in body fat mass
기간: Baseline and 6 months
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Body fat mass (BFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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Change in fat-free mass
기간: Baseline and 6 months
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Fat-free mass (FFM), measured in kilograms using bioelectrical impedance analysis with an InBody analyzer.
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Baseline and 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Truc T Thanh, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
간행물 및 유용한 링크
일반 간행물
- Dike IC, Ebizie EN, Chukwuone CA, Ejiofor NJ, Anowai CC, Ogbonnaya EK, Ugwu EI, Nkechinyere US, Chigbu EF, Ezeaku MN, Nnadi GC, Ihuoma EC, Gera NP, Chikwendu JN. Effect of community-based nutritional counseling intervention on children's eating habits. Medicine (Baltimore). 2021 Jul 30;100(30):e26563. doi: 10.1097/MD.0000000000026563.
- Annan RA, Apprey C, Agyemang GO, Tuekpe DM, Asamoah-Boakye O, Okonogi S, Yamauchi T, Sakurai T. Nutrition education improves knowledge and BMI-for-age in Ghanaian school-aged children. Afr Health Sci. 2021 Jun;21(2):927-941. doi: 10.4314/ahs.v21i2.55.
- Truong DTT, Tran THT, Nguyen TTT, Tran VHT. Double burden of malnutrition in ethnic minority school-aged children living in mountainous areas of Vietnam and its association with nutritional behavior. Nutr Res Pract. 2022 Oct;16(5):658-672. doi: 10.4162/nrp.2022.16.5.658. Epub 2022 Jan 25.
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
- IRB No. 493/HDDD-DHYD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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