Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents (MEGA) Program - MEGA 2.0
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 1. Moderate to severe anemia in adolescents
研究概览
简要总结
The overall objective of the proposed study is to determine the longer-term effectiveness and implementation of an updated school-based nutrition intervention package for reducing adolescent malnutrition. Aim 1 of the study is to determine the longer-term effectiveness of an updated intervention package on reducing adolescent malnutrition using a cluster randomized controlled trial in Dodoma, Tanzania. Four intervention schools and two control schools will be included. The intervention schools will receive an intervention package that includes school feeding, nutrition education, school vegetable garden, community workshops, and weekly iron and folic acid supplementation and annual deworming. The control schools will not receive any intervention. The intervention package will be implemented over one year. In each school, 125 adolescents aged between 14 and 17 and 125 mothers/female guardians will be enrolled. The primary outcomes will be moderate to severe anemia in adolescents and underweight in adolescents. The secondary outcomes will include anemia (any severity) and overweight/obesity in adolescents, diet quality in adolescents and mothers/female guardians, household food insecurity, and women's empowerment for mothers/female guardians. A baseline and an end-line evaluation of the outcomes will be implemented. Aim 2 of the study will be to assess the implementation of the updated intervention package by collecting quantitative and qualitative data from adolescents, mothers/female guardians, teachers, smallholder farmers, agricultural extension workers, school administrators, and governmental stakeholders. Using a convergent mixed methods approach, quantitative data (via questionnaires) and qualitative data (via semi-structured interviews and focus group discussions) will be analyzed to evaluate the implementation of the intervention package and identify its implementation barriers and facilitators.
详细描述
This study will be a cluster-randomized controlled study and will use a mixed-methods approach to evaluate the longer-term effectiveness and implementation of an updated school-based intervention package on adolescent nutritional status in six public secondary schools in Chamwino District, Dodoma, Tanzania. Specifically:
- Aim 1 of the study is to determine the longer-term effectiveness of the updated school-based intervention package on reducing adolescent malnutrition.
- Aim 2 of the study is to assess the implementation of the updated school-based intervention package.
Study Design
This is a two-arm study comparing an intervention group to a control group. Four schools will be assigned to the intervention arm, and two schools will be assigned to the control arm. The study duration is one academic year. Baseline and endline data collection will occur at the beginning and end of the academic year, respectively. Implementation and sustainability data will be collected towards the end of the intervention period.
Intervention Arm (MEGA 2.0 Package)
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
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent Quantitative Survey:
- •Student enrolled in Form 1 or 2 in a participating school
- •Between the ages of 14-17
- •Parent or guardian provides consent for the adolescent
- •Adolescent provides assent
- •Fluent in Swahili
- •Adolescent Qualitative Focus Group Discussion (FGD):
- •Student enrolled in Form 1 or 2 in a participating school
- •Between the ages of 14-17
- •Identified by their teacher as a suitable candidate for the focus group
- •Parent or guardian provides consent for the adolescent
- •Adolescent provides assent
- •Fluent in Swahili
- •Mother Quantitative Survey and Qualitative FGD:
- •Mother or female guardian of participating adolescent
- •Provides informed consent
- •Fluent in Swahili
- •Focal Teacher Qualitative Semi-Structured Interview (SSI):
- •Teacher facilitating the meal, garden, education, and supplementation interventions
- •Provides informed consent
- •Fluent in Swahili
- •Smallholder Farmer Qualitative SSI:
- •Farmers involved in the provision of local produce for school feeding
- •Provides informed consent
- •Fluent in Swahili or English
- •Agricultural Extension Worker Qualitative SSI:
- •Extension workers involved in school garden and community workshops
- •Provides informed consent
- •Fluent in Swahili
- •School Administrator Qualitative SSI:
- •School administrators involved in the intervention
- •Provides informed consent
- •Fluent in Swahili
排除标准
- •Those who do not meet the above listed inclusion criteria.
研究组 & 干预措施
Intervention
School meals, gardens, education, iron and folic acid supplementation, and workshops for women.
干预措施: IFA and Deworming (Dietary Supplement)
Intervention
School meals, gardens, education, iron and folic acid supplementation, and workshops for women.
干预措施: School meals (Other)
Intervention
School meals, gardens, education, iron and folic acid supplementation, and workshops for women.
干预措施: School gardens (Other)
Intervention
School meals, gardens, education, iron and folic acid supplementation, and workshops for women.
干预措施: Nutrition education (Behavioral)
Intervention
School meals, gardens, education, iron and folic acid supplementation, and workshops for women.
干预措施: Women's workshops (Behavioral)
Control
Standard of care
结局指标
主要结局
1. Moderate to severe anemia in adolescents
时间窗: Baseline and endline (approximately 12 months after baseline)
Hemoglobin concentration \< 110 g/L in girls and boys
Underweight in adolescents
时间窗: Baseline and endline (approximately 12 months after baseline)
BMI-for-age z-score \< -2 by WHO growth reference
次要结局
- Anemia (any severity) in adolescents(Baseline and endline (approximately 12 months after baseline))
- Overweight or obesity in adolescents(Baseline and endline (approximately 12 months after baseline))
- Diet quality of adolescents(Baseline and endline (approximately 12 months after baseline))
- Diet quality of mothers(Baseline and endline (approximately 12 months after baseline))
- Household food insecurity(Baseline and endline (approximately 12 months after baseline))
- Women's empowerment in mothers(Baseline and endline (approximately 12 months after baseline))
研究者
Wafaie Fawzi
Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)