Meals, Education, and Gardens for In-School Adolescents (MEGA) Project (MEGA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04788303 |
|
Recruitment Status :
Active, not recruiting
First Posted : March 9, 2021
Last Update Posted : May 16, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anemia | Other: School meal, garden, education, and community workshops Other: Garden, education, and community workshops | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 1536 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 |
| Actual Study Start Date : | January 24, 2022 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
| 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
|
- 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
- Height [ Time Frame: Up to one year ]Adolescent height will be measured in centimeters.
- Weight [ Time Frame: Up to one year. ]Adolescent weight will be measured in kilograms.
- BMI [ Time Frame: Up to one year ]Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Home gardening practices among parents [ Time Frame: Up to one year ]To be assessed using self-reported home gardening practice by parents.
- Dietary practice among parents [ Time Frame: Up to one year ]To be assessed using a food frequency questionnaire among parents.
- Nutrition knowledge among parents [ Time Frame: Up to one year ]To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 14 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| Tanzania | |
| University of Dodoma | |
| Dodoma, Tanzania | |
| Principal Investigator: | Wafaie W Fawzi, MBBS, MPH, MS, DrPH | Harvard School of Public Health (HSPH) |
| Responsible Party: | Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health (HSPH) |
| ClinicalTrials.gov Identifier: | NCT04788303 |
| Other Study ID Numbers: |
CNSG Project |
| First Posted: | March 9, 2021 Key Record Dates |
| Last Update Posted: | May 16, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Anemia School garden School lunch Nutrition Adolescent health |
|
Anemia Hematologic Diseases |