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临床试验/NCT06815315
NCT06815315已完成不适用

A Formative, Mixed-Methods Evaluation Assessing the Acceptability, Feasibility, and Effectiveness of Micronutrient Interventions Among Adolescents in Mozambique

World Vision US1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
490
试验地点
1
主要终点
Anemia Status

研究概览

简要总结

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and the impact of a nutrition curriculum on diet diversity and anemia knowledge among adolescent girls.

详细描述

This study aimed to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health, and education in Mozambique. In conjunction with the Mozambique Ministries of Health, Education and Culture, we conducted a two-arm cluster-randomized trial in three secondary schools, enrolling 28 girls' clubs (14 per arm). Each club was comprised of around 18 girls aged 13 to 20 years. Using constrained sampling to balance for age and school, clubs were randomly assigned to one of two intervention groups: 1) Multiple Micronutrient Supplementation (MMS) for five months plus a Nutrition Curriculum, or 2) Iron and Folic Acid Supplementation (IFAS) plus a Nutrition Curriculum. Girls enrolled in the MMS arm consumed supplements daily for 4 months at home and weekly nutrition messages delivered through the clubs. Girls enrolled in the IFAS arm consumed supplements once a week for 4 months at school (the standard of care) and weekly nutrition messages delivered through the clubs. The study evaluated the effects of MMS and IFAS on anemia status and the impact of the nutrition curriculum on diet diversity and anemia knowledge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Adolescents aged 13-20 years Enrolled in secondary school at study initiation Member of an IMPACT+ Girls Club at one of the participating schools Consent provided by the parent Assent provided by the adolescent

排除标准

  • •No informed consent from parent or assent from adolescent Self-reported pregnancy

研究组 & 干预措施

Multiple Micronutrient Supplementation (MMS) Arm

Active Comparator

The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages.

干预措施: Multiple micronutrient supplementation (Dietary Supplement)

Multiple Micronutrient Supplementation (MMS) Arm

Active Comparator

The adolescent girls randomly assigned to the MMS arm consumed MMS for four months and participated in girls' clubs where they received nutrition messages.

干预措施: Adolescent Nutrition Curriculum (Behavioral)

Iron Folic Acid Supplementation (IFAS) Arm

Active Comparator

The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages

干预措施: Iron Folic Acid Supplementation (Dietary Supplement)

Iron Folic Acid Supplementation (IFAS) Arm

Active Comparator

The adolescent girls randomly assigned to the IFAS arm consumed IFAS for four months and participated in girls' clubs where they received nutrition messages

干预措施: Adolescent Nutrition Curriculum (Behavioral)

结局指标

主要结局

Anemia Status

时间窗: 6 months

Anemia is defined as hemoglobin level \<10 g/dL

次要结局

  • Anemia Knowledge(6 months)
  • Minimum Dietary Diversity Score(6 months)

研究者

发起方
World Vision US
申办方类型
Other
责任方
Sponsor

研究点 (1)

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