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

Primary Purpose

Anemia

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
School meal, garden, education, and community workshops
Garden, education, and community workshops
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring Anemia, School garden, School lunch, Nutrition, Adolescent health

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Dodoma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Full intervention

Partial intervention

Control

Arm Description

Full intervention: school meal, garden, education, and community workshops

Partial intervention: garden, education, and community workshops

Control: standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Height
Adolescent height will be measured in centimeters.
Weight
Adolescent weight will be measured in kilograms.
BMI
Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards).
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.
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.
Practices of adolescents regarding nutrition and dietary intake
Nutritional and dietary practices will be assessed using a food frequency questionnaire.
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.
Educational outcomes of adolescents (school attendance)
School attendance will be measured as number of school days missed per student.
Educational outcomes of adolescents (School retention)
School retention will be measured as number of students who drop out of school.
Practices of WASH among parents
To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene.
Home gardening practices among parents
To be assessed using self-reported home gardening practice by parents.
Dietary practice among parents
To be assessed using a food frequency questionnaire among parents.
Nutrition knowledge among parents
To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake.

Full Information

First Posted
February 20, 2021
Last Updated
May 1, 2023
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Africa Academy for Public Health, University of Dodoma
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1. Study Identification

Unique Protocol Identification Number
NCT04788303
Brief Title
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Acronym
MEGA
Official Title
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Africa Academy for Public Health, University of Dodoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, School garden, School lunch, Nutrition, Adolescent health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full intervention
Arm Type
Active Comparator
Arm Description
Full intervention: school meal, garden, education, and community workshops
Arm Title
Partial intervention
Arm Type
Active Comparator
Arm Description
Partial intervention: garden, education, and community workshops
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control: standard of care
Intervention Type
Other
Intervention Name(s)
School meal, garden, education, and community workshops
Other Intervention Name(s)
Full intervention package
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Garden, education, and community workshops
Other Intervention Name(s)
Partial intervention package
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anemia status
Description
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
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Height
Description
Adolescent height will be measured in centimeters.
Time Frame
Up to one year
Title
Weight
Description
Adolescent weight will be measured in kilograms.
Time Frame
Up to one year.
Title
BMI
Description
Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards).
Time Frame
Up to one year
Title
Knowledge of adolescents regarding nutrition and dietary intake
Description
Adolescents' knowledge of nutrition will be assessed by questions that evaluate their levels of nutrition-related knowledge.
Time Frame
Up to one year
Title
Attitudes of adolescents regarding nutrition and dietary intake
Description
Adolescents' attitudes of nutrition will be assessed by evaluating their preferences of food groups using Likert scales.
Time Frame
Up to one year
Title
Practices of adolescents regarding nutrition and dietary intake
Description
Nutritional and dietary practices will be assessed using a food frequency questionnaire.
Time Frame
Up to one year
Title
Practices of adolescents regarding water, sanitation, and hygiene
Description
Adolescents' practices of WASH will be assessed by questions that evaluate their WASH-related behaviors such as handwashing.
Time Frame
Up to one year
Title
Educational outcomes of adolescents (school attendance)
Description
School attendance will be measured as number of school days missed per student.
Time Frame
Up to one year
Title
Educational outcomes of adolescents (School retention)
Description
School retention will be measured as number of students who drop out of school.
Time Frame
Up to one year
Title
Practices of WASH among parents
Description
To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene.
Time Frame
Up to one year
Title
Home gardening practices among parents
Description
To be assessed using self-reported home gardening practice by parents.
Time Frame
Up to one year
Title
Dietary practice among parents
Description
To be assessed using a food frequency questionnaire among parents.
Time Frame
Up to one year
Title
Nutrition knowledge among parents
Description
To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake.
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Fawzi, MBBS, MPH, MS, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Dodoma
City
Dodoma
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35798513
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.
Results Reference
derived

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

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