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

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ClinicalTrials.gov Identifier: NCT04788303
Recruitment Status : Not yet recruiting
First Posted : March 9, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Africa Academy for Public Health
University of Dodoma
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia Other: School meal, garden, education, and community workshops Other: Garden, education, and community workshops Not Applicable

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 Form 1 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, Form 1 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Estimated Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Full intervention
Full intervention: school meal, garden, education, and community workshops
 Other: 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 Name: Full intervention package
Active Comparator: Partial intervention
Partial intervention: garden, education, and community workshops
 Other: 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 Name: Partial intervention package
No Intervention: Control
Control: standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Height [ Time Frame: Up to one year ]
    Adolescent weight will be measured in cm

  2. Weight [ Time Frame: Up to one year ]
    Adolescent weight will be measured in kg

  3. School attendance [ Time Frame: Up to one year ]
    School attendance will be measured as number of school days missed per student

  4. School retention [ Time Frame: Up to one year ]
    School retention will be measured as number of students who drop out of school


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Adolescents:

  • Adolescents aged 14-17 years
  • Enrolled in secondary school form 1 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788303


Contacts
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Contact: Wafaie W Fawzi, MBBS, MPH, MS, DrPH 617.432.7598 mina@hsph.harvard.edu
Contact: Tara J Young, MPH 617.432.5330 Tyoung@hsph.harvard.edu

Locations
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Tanzania
University of Dodoma
Dodoma, Tanzania
Contact: Leonard K Katalambula, MSc, PhD    +255 758 921000    katalambula@gmail.com   
Principal Investigator: Leonard K Katalambula, MSc, PhD         
Sponsors and Collaborators
Harvard School of Public Health
Africa Academy for Public Health
University of Dodoma
Investigators
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Principal Investigator: Wafaie W Fawzi, MBBS, MPH, MS, DrPH Harvard School of Public Health
More Information
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Responsible Party: Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT04788303    
Other Study ID Numbers: CNSG Project
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wafaie Fawzi, Harvard School of Public Health:
Anemia
School garden
School lunch
Nutrition
Adolescent health
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases