- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788303
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project (MEGA)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dodoma, Tanzania
- University of Dodoma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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:
|
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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