Clinical trial NCT04788303: Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Official title: Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
School garden
School lunch
Nutrition
Adolescent health
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Africa Academy for Public Health
name: University of Dodoma
First posted: 2021-03-09
Enrollment: 1232
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Anemia status
timeFrame: Up to one year
Secondary outcomes:
measure: Height
timeFrame: Up to one year
measure: Weight
timeFrame: Up to one year.
measure: BMI
timeFrame: Up to one year
measure: Knowledge of adolescents regarding nutrition and dietary intake
timeFrame: Up to one year
measure: Attitudes of adolescents regarding nutrition and dietary intake
timeFrame: Up to one year
measure: Practices of adolescents regarding nutrition and dietary intake
timeFrame: Up to one year
measure: Practices of adolescents regarding water, sanitation, and hygiene
timeFrame: Up to one year
measure: Educational outcomes of adolescents (school attendance)
timeFrame: Up to one year
measure: Educational outcomes of adolescents (School retention)
timeFrame: Up to one year
measure: Practices of WASH among parents
timeFrame: Up to one year
measure: Home gardening practices among parents
timeFrame: Up to one year
measure: Dietary practice among parents
timeFrame: Up to one year
measure: Nutrition knowledge among parents
timeFrame: Up to one year
Other outcomes:
Locations:
city: Dodoma
country: Tanzania
facility: University of Dodoma
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MBBS, MPH, MS, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Katalambula LK, Modest AR, Young T, Ismail A, Mwanyika-Sando M, Tinkasimile A, Mosha D, Malero A, Vuai S, Fawzi WW. Meals, Education, and Gardens for In-School Adolescents (MEGA): study protocol for a cluster randomised trial of an integrated adolescent nutrition intervention in Dodoma, Tanzania. BMJ Open. 2022 Jul 7;12(7):e062085. doi: 10.1136/bmjopen-2022-062085.