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

May 1, 2023 updated by: Wafaie Fawzi, Harvard School of Public Health (HSPH)
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

1232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dodoma, Tanzania
        • University of Dodoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Full intervention
Full intervention: school meal, garden, education, and community workshops

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.

Other Names:
  • Full intervention package
Active Comparator: Partial intervention
Partial intervention: garden, education, and community workshops

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.

Other Names:
  • Partial intervention package
No Intervention: Control
Control: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia status
Time Frame: Up to one year

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
Time Frame: Up to one year
Adolescent height will be measured in centimeters.
Up to one year
Weight
Time Frame: Up to one year.
Adolescent weight will be measured in kilograms.
Up to one year.
BMI
Time Frame: Up to one year
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
Time Frame: Up to one year
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
Time Frame: Up to one year
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
Time Frame: Up to one year
Nutritional and dietary practices will be assessed using a food frequency questionnaire.
Up to one year
Practices of adolescents regarding water, sanitation, and hygiene
Time Frame: Up to one year
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)
Time Frame: Up to one year
School attendance will be measured as number of school days missed per student.
Up to one year
Educational outcomes of adolescents (School retention)
Time Frame: Up to one year
School retention will be measured as number of students who drop out of school.
Up to one year
Practices of WASH among parents
Time Frame: Up to one year
To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene.
Up to one year
Home gardening practices among parents
Time Frame: Up to one year
To be assessed using self-reported home gardening practice by parents.
Up to one year
Dietary practice among parents
Time Frame: Up to one year
To be assessed using a food frequency questionnaire among parents.
Up to one year
Nutrition knowledge among parents
Time Frame: Up to one year
To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake.
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

February 20, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNSG Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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