AnemiaMEGANCT04788303
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
A study testing School meal, garden, education, and community workshops and Garden, education, and community workshops in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- School meal, garden, education, and community workshops and Garden, education, and community workshops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,232 participants
- Where
- 1 siteTanzania
- Study dates
- 24 Jan 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Adolescents:
- No informed consent from parent/guardian or assent from adolescent
- Parents:
- No informed consent
- Teachers:
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- School meal, garden, education, and community workshops, Garden, education, and community workshops
- Keywords
- Anemia, School garden, School lunch, Nutrition, Adolescent health
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School meal, garden, education, and community workshopsOther
Also called Full intervention package
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.
Garden, education, and community workshopsOther
Also called Partial intervention package
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.
| Study group | Role | What they receive |
|---|---|---|
| Full intervention | Active comparator | Full intervention: school meal, garden, education, and community workshops Receives: Other: School meal, garden, education, and community workshops |
| Partial intervention | Active comparator | Partial intervention: garden, education, and community workshops Receives: Other: Garden, education, and community workshops |
| Control | No intervention | Control: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to one year
Secondary outcomes (13)
Height
Adolescent height will be measured in centimeters.
Measured: Up to one year
Weight
Adolescent weight will be measured in kilograms.
Measured: Up to one year.
BMI
Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards).
Measured: Up to one year
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.
Measured: Up to one year
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.
Measured: Up to one year
Practices of adolescents regarding nutrition and dietary intake
Nutritional and dietary practices will be assessed using a food frequency questionnaire.
Measured: Up to one year
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.
Measured: Up to one year
Educational outcomes of adolescents (school attendance)
School attendance will be measured as number of school days missed per student.
Measured: Up to one year
Educational outcomes of adolescents (School retention)
School retention will be measured as number of students who drop out of school.
Measured: Up to one year
Practices of WASH among parents
To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene.
Measured: Up to one year
Home gardening practices among parents
To be assessed using self-reported home gardening practice by parents.
Measured: Up to one year
Dietary practice among parents
To be assessed using a food frequency questionnaire among parents.
Measured: Up to one year
Nutrition knowledge among parents
To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start24 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Africa Academy for Public Health, University of Dodoma
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, MPH, MS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788303
- Sponsor's protocol ID
- CNSG Project
- Acronym
- MEGA
- Status last verified
- May 2023
- First submitted
- 20 Feb 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35798513
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
- ClinicalTrials.gov ID
- NCT04788303
- Acronym / sponsor ID
- MEGA / CNSG Project
- Conditions
- Anemia
- Keywords
- Anemia, School garden, School lunch, Nutrition, Adolescent health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Africa Academy for Public Health, University of Dodoma
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full intervention | Active comparator | Other: School meal, garden, education, and community workshopsFull intervention: school meal, garden, education, and community workshops |
| Partial intervention | Active comparator | Other: Garden, education, and community workshopsPartial intervention: garden, education, and community workshops |
| Control | No intervention | –Control: standard of care |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- No informed consent from parent/guardian or assent from adolescent
- No informed consent
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School meal, garden, education, and community workshopsAlso: Full intervention packageSchool 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 | Full intervention |
| Garden, education, and community workshopsAlso: Partial intervention packageSchool 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 | Partial intervention |
Primary outcome
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
13 secondary outcomes
Height
Time frame: Up to one year
Weight
Time frame: Up to one year.
BMI
Time frame: Up to one year
Knowledge of adolescents regarding nutrition and dietary intake
Time frame: Up to one year
Attitudes of adolescents regarding nutrition and dietary intake
Time frame: Up to one year
Practices of adolescents regarding nutrition and dietary intake
Time frame: Up to one year
Practices of adolescents regarding water, sanitation, and hygiene
Time frame: Up to one year
Educational outcomes of adolescents (school attendance)
Time frame: Up to one year
Educational outcomes of adolescents (School retention)
Time frame: Up to one year
Practices of WASH among parents
Time frame: Up to one year
Home gardening practices among parents
Time frame: Up to one year
Dietary practice among parents
Time frame: Up to one year
Nutrition knowledge among parents
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 35798513Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaie W Fawzi, MBBS, MPH, MS, DrPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School meal, garden, education, and community workshops and Garden, education, and community workshops in people with Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia status (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.