跳至主要内容
临床试验/NCT06827964
NCT06827964尚未招募不适用

Effects of Nutrition Package (Yingyangbao) Intervention on Children and Adolescents' Health in Myanmar

Tsinghua University0 个研究点目标入组 600 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
Physical examination

研究概览

简要总结

The goal of this cluster randomized controlled trial is to study the effectiveness of the Nutrition Package (Yingyangbao) on improving malnutrition in children and adolescents aged 7-15 in Myanmar. The main questions it aims to answer are:

  • What is the effectiveness of Nutrition Package intervention on the growth, development, and nutritional health of children and adolescents aged 7-15 in Myanmar?
  • How safe and feasible is the Nutrition package? Researchers will compare the Nutrition Package plus probiotics, the Nutrition Package alone, and no intervention to see if the Nutrition Package improves malnutrition and other health outcomes of children and adolescents aged 7-15 in Myanmar.

Participants will receive Nutrition Package products for six months and have their height, weight, mid-upper arm circumference, and hemoglobin levels measured and compared at baseline and end.

详细描述

Study background:

Malnutrition among children and adolescents is a significant public health issue in developing countries, including Myanmar, severely affecting children and adolescents' growth, development, and overall health, and potentially leading to long-term adverse health outcomes or even death. Influenced by factors such as armed conflicts, the COVID-19 pandemic, and natural disasters, malnutrition in Myanmar has become even more pronounced.

Preliminary cross-sectional survey results indicate that the malnutrition rate among children and adolescents aged 7-15 in Special Region 4 of Myanmar is as high as 56.2%, with stunting, wasting (in children under 10), and underweight rates at 53.2%, 38.5%, and 5.0%, respectively. Additionally, health issues such as diarrhea, fever, skin and hair problems, and functional impairments are prevalent, with detection rates exceeding 40%. Analysis of influencing factors reveals that diet is a critical determinant of growth and development in this population. Nutrient assessments show insufficient daily intake of essential nutrients, including vitamin A, vitamin B1, vitamin B2, calcium, iron, and zinc. Children and adolescents aged 7-15 are in a critical period of growth and development, and nutrient deficiencies can lead to severe adverse health effects. Moreover, the prevalence of diseases such as diarrhea and fever may further impair nutrient absorption, creating a vicious cycle of malnutrition. Malnutrition among children and adolescents has become an urgent public health issue in Myanmar, necessitating interventions to improve these people's nutritional health.

Nutrition package, recommended by the WHO, has been proven effective in reducing the risks of anemia, stunting, underweight, and wasting in children under 5 in China. However, there is limited evidence on its effectiveness for older children and adolescents. Expert discussions have concluded that the current nutrition package formula, administered at a dose of two sachets per day, can meet the average nutrient requirements for different genders and age groups without exceeding the tolerable upper intake levels. The addition of probiotics to the nutrition packages may further enhance nutrient absorption, boost immune function, and reduce gastrointestinal diseases. The prior survey results indicate that children and adolescents in Special Region 4 of Myanmar currently do not have access to nutritional supplements, yet 98% of participants reported acceptance after using the nutrition package products. Therefore, implementing these nutritional interventions in this region might be safe, cost-effective, and feasible.

Based on the above facts, this study aims to conduct a pilot intervention using nutrition package among children and adolescents aged 7-15 in Special Region 4 of Myanmar. The goal is to evaluate the effectiveness and safety of these packages in improving the nutritional health of this population, providing essential scientific data to further enhance the growth, development, and nutritional health of children and adolescents in Myanmar.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents aged 7-15 years.
  • Residing in the local area for more than 1 year.

排除标准

  • Individuals with severe metabolic diseases.
  • Diagnosed with HIV/AIDS.
  • Individuals with physical disabilities.
  • Individuals with severe mental conditions that may hinder their ability to cooperate with the study.
  • Those who have received other nutritional supplementation packages or fortified foods in the past 6 months.
  • Individuals with a history of intestinal diseases, other severe digestive system disorders, or metabolic disorders.

结局指标

主要结局

Physical examination

时间窗: At the enrollment, later 3 month and later 6 month.

Height and weight are measured using a height and weight meter, and mid-upper arm circumference is measured using an arm circumference ruler.

次要结局

  • Hemoglobin determination(At the enrollment, later 3 month and later 6 month.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ai Zhao

Associate Professor

Tsinghua University

相似试验