Meals, Education, and Gardens for In-School Adolescents (MEGA) Project

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to assess effects of a comprehensive, school-based nutrition intervention package on anemia status, anthropometric indicators, school performance/attendance, and development indicators among adolescents, and the knowledge, attitudes, and practices of nutrition, agriculture, and WASH among parents, in Tanzania.

Detailed Description
-----------------
The Meals, Education, and Gardens for In-School Adolescents (MEGA) Project aims to implement and evaluate a comprehensive, school-based nutrition intervention package among secondary schools in Dodoma, Tanzania. The intervention will include four primary components: (1) school garden, (2) school meal program, (3) agriculture, nutrition, and water, sanitation, and hygiene (WASH) education, and (4) community workshops. This will be a cluster randomized trial with 3 arms, containing two schools each. At the beginning of the academic year, six schools will be randomized to intervention or control. Two schools will receive the full intervention package (school lunch, school garden, and education), two schools will receive the partial intervention package (school garden and education), and two schools will serve as control to receive the standard of care. Community workshops will also be provided to parents of adolescents in full and partial intervention schools. In the full intervention schools, all adolescents will receive a midday meal, while a subset of Forms 1 or 2 adolescents will additionally participate in a school gardening program that includes nutrition, agriculture, and water, sanitation, and hygiene (WASH) education, led by selected teachers. Parents of adolescents in full intervention schools will be invited to participate in community workshops on nutrition, hygiene, and agricultural best practices, led by community Agriculture Extension Workers (AEWs). In the partial intervention schools, Forms 1 or 2 adolescents will participate in the gardening and education components described above, but will not receive the midday meal. Parents of participating adolescents will also be invited to participate in the community workshops. Adolescents in control schools will not receive any of these interventions but will be provided with standard of care practices at secondary schools in Dodoma. In addition, teachers in control schools will receive a hard copy of educational materials on nutrition, agriculture, and WASH to enhance their lesson plans. The intervention will take place over the course of one year. The goal of the MEGA project is to study the effects of the integrated intervention on the nutrition and health of adolescents and their families in Tanzania. Ultimately, we aim to use the findings from this study to inform the scale-up of future school and community-based interventions to improve nutrition through training, improved crop production, and increased consumption of vegetables.

Official Title
-----------------
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Other: School meal, garden, education, and community workshops
* Other: Garden, education, and community workshops


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Adolescents: Adolescents aged 14-17 years Enrolled in secondary school forms 1 or 2 at study initiation Member of one of the selected classes in a participating school Consent provided by the parent Assent provided by the adolescent Fluent in Swahili or English Parents: Parent or guardian of participating adolescent Provides informed consent Fluent in Swahili or English Teachers: Teacher facilitating the meal, garden, and/or education interventions Provides informed consent Fluent in Swahili or English EXCLUSION CRITERIA: Adolescents: No informed consent from parent/guardian or assent from adolescent Parents: No informed consent Teachers: No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Six schools will be randomly assigned to receive the full intervention (school meal, garden, and education), partial intervention (garden and education), or control (standard of care). Community workshops will also be provided to parents of adolescents in full and partial intervention schools.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full intervention<br>Full intervention: school meal, garden, education, and community workshops | Other: School meal, garden, education, and community workshops<br>* School meal: midday meal provided at intervention schools School garden: garden used to grow crops (which will be used to supplement the school meal in the full intervention schools) Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.<br>* Other names: Full intervention package;|
| Active Comparator: Partial intervention<br>Partial intervention: garden, education, and community workshops | Other: Garden, education, and community workshops<br>* School garden: garden used to grow crops Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.<br>* Other names: Partial intervention package;|
| No Intervention: Control<br>Control: standard of care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia status | Anemia status will be defined using the diagnostic criteria by the World Health Organization. Specifically, the following criteria will be used: < 12 g/dL for adolescent girls and adolescent boys aged 14 yrs and < 13 g/dL for adolescent boys aged 15-19 yrs | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Adolescent height will be measured in centimeters. | Up to one year | 
| Weight | Adolescent weight will be measured in kilograms. | Up to one year. | 
| BMI | Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards). | Up to one year | 
| Knowledge of adolescents regarding nutrition and dietary intake | Adolescents' knowledge of nutrition will be assessed by questions that evaluate their levels of nutrition-related knowledge. | Up to one year | 
| Attitudes of adolescents regarding nutrition and dietary intake | Adolescents' attitudes of nutrition will be assessed by evaluating their preferences of food groups using Likert scales. | Up to one year | 
| Practices of adolescents regarding nutrition and dietary intake | Nutritional and dietary practices will be assessed using a food frequency questionnaire. | Up to one year | 
| Practices of adolescents regarding water, sanitation, and hygiene | Adolescents' practices of WASH will be assessed by questions that evaluate their WASH-related behaviors such as handwashing. | Up to one year | 
| Educational outcomes of adolescents (school attendance) | School attendance will be measured as number of school days missed per student. | Up to one year | 
| Educational outcomes of adolescents (School retention) | School retention will be measured as number of students who drop out of school. | Up to one year | 
| Practices of WASH among parents | To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene. | Up to one year | 
| Home gardening practices among parents | To be assessed using self-reported home gardening practice by parents. | Up to one year | 
| Dietary practice among parents | To be assessed using a food frequency questionnaire among parents. | Up to one year | 
| Nutrition knowledge among parents | To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake. | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, School garden, School lunch, Nutrition, Adolescent health