AnemiaMEGA 2NCT07092150
Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents Program
A study testing School meals, School gardens and IFA and Deworming in people with Anemia and Nutritional Status, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.
Trial summary
The overall objective of the proposed study is to determine the longer-term effectiveness and implementation of an updated school-based nutrition intervention package for reducing adolescent malnutrition. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Nutritional Status
- What is being tested?
- School meals, School gardens and IFA and Deworming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteTanzania
- Study dates
- 19 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adolescent Quantitative Survey:
- Student enrolled in Form 1 or 2 in a participating school
- Between the ages of 14-17
- Parent or guardian provides consent for the adolescent
- Adolescent provides assent
- Fluent in Swahili
Show all 33Show fewer
- Adolescent Qualitative Focus Group Discussion (FGD):
- Student enrolled in Form 1 or 2 in a participating school
- Between the ages of 14-17
- Identified by their teacher as a suitable candidate for the focus group
- Parent or guardian provides consent for the adolescent
- Adolescent provides assent
- Fluent in Swahili
- Mother Quantitative Survey and Qualitative FGD:
- Mother or female guardian of participating adolescent
- Provides informed consent
- Fluent in Swahili
- Focal Teacher Qualitative Semi-Structured Interview (SSI):
- Teacher facilitating the meal, garden, education, and supplementation interventions
- Provides informed consent
- Fluent in Swahili
- Smallholder Farmer Qualitative SSI:
- Farmers involved in the provision of local produce for school feeding
- Provides informed consent
- Fluent in Swahili or English
- Agricultural Extension Worker Qualitative SSI:
- Extension workers involved in school garden and community workshops
- Provides informed consent
- Fluent in Swahili
- School Administrator Qualitative SSI:
- School administrators involved in the intervention
- Provides informed consent
- Fluent in Swahili
Who cannot join
- Those who do not meet the above listed inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents (MEGA) Program - MEGA 2.0
The overall objective of the proposed study is to determine the longer-term effectiveness and implementation of an updated school-based nutrition intervention package for reducing adolescent malnutrition. Aim 1 of the study is to determine the longer-term effectiveness of an updated intervention package on reducing adolescent malnutrition using a cluster randomized controlled trial in Dodoma, Tanzania. Four intervention schools and two control schools will be included. The intervention schools will receive an intervention package that includes school feeding, nutrition education, school vegetable garden, community workshops, and weekly iron and folic acid supplementation and annual deworming. The control schools will not receive any intervention. The intervention package will be implemented over one year. In each school, 125 adolescents aged between 14 and 17 and 125 mothers/female guardians will be enrolled. The primary outcomes will be moderate to severe anemia in adolescents and underweight in adolescents. The secondary outcomes will include anemia (any severity) and overweight/obesity in adolescents, diet quality in adolescents and mothers/female guardians, household food insecurity, and women's empowerment for mothers/female guardians. A baseline and an end-line evaluation of the outcomes will be implemented. Aim 2 of the study will be to assess the implementation of the updated intervention package by collecting quantitative and qualitative data from adolescents, mothers/female guardians, teachers, smallholder farmers, agricultural extension workers, school administrators, and governmental stakeholders. Using a convergent mixed methods approach, quantitative data (via questionnaires) and qualitative data (via semi-structured interviews and focus group discussions) will be analyzed to evaluate the implementation of the intervention package and identify its implementation barriers and facilitators.
Read the detailed description
This study will be a cluster-randomized controlled study and will use a mixed-methods approach to evaluate the longer-term effectiveness and implementation of an updated school-based intervention package on adolescent nutritional status in six public secondary schools in Chamwino District, Dodoma, Tanzania. Specifically:
- Aim 1 of the study is to determine the longer-term effectiveness of the updated school-based intervention package on reducing adolescent malnutrition.
- Aim 2 of the study is to assess the implementation of the updated school-based intervention package.
Study Design
This is a two-arm study comparing an intervention group to a control group. Four schools will be assigned to the intervention arm, and two schools will be assigned to the control arm. The study duration is one academic year. Baseline and endline data collection will occur at the beginning and end of the academic year, respectively. Implementation and sustainability data will be collected towards the end of the intervention period.
Intervention Arm (MEGA 2.0 Package)
The MEGA 2.0 intervention is a unified package delivered to adolescents in intervention schools, comprising five integrated components:
- School Feeding: Daily midday meals provided to all adolescents in intervention schools, meeting 60-75% of their daily energy and nutritional requirements. Meals will consist of traditional Tanzanian staples, green leafy vegetables, and will integrate local produce from farm-to-school partnerships and school gardens. School meal committees involving parents, teachers, and administrators will be established to enhance sustainability and community buy-in, with opportunities for mothers to be employed as cooks.
- School Gardens: Establishment of a vegetable garden in each intervention school. Adolescents will participate in gardening activities under the supervision of a trained focal teacher. Agricultural extension workers will provide technical support.
- Nutrition Education: Weekly sessions for adolescents led by focal teachers, covering health and nutrition, agriculture and school gardening, health benefits of vegetables, physical activity and body size, and WASH (Water, Sanitation, and Hygiene).
- Community Workshops: Bi-weekly workshops for mothers and female guardians, conducted by agricultural extension workers. Workshops will utilize school gardens as "model farms" and cover nutrition, agriculture, WASH, and entrepreneurship skills. Participants will receive seeds and gardening supplies as feasible for homestead gardens and guidance on local market entry and microfinancing schemes.
- Weekly Iron and Folic Acid (IFA) Supplementation and Annual Deworming: Weekly IFA supplements will be administered to adolescents by focal teachers during nutrition education sessions. Annual deworming with mebendazole (500 mg) will also be provided.
Control Arm
Adolescents in control schools will not receive any study interventions. They will continue with standard of care practices at secondary schools in Dodoma. Currently, standard of care in Tanzania does not include school meals or government-run school feeding programs in secondary schools. Teachers in control schools will receive a hard copy of educational materials on nutrition, agriculture, and WASH to enhance their lesson plans and a community workshop manual, to use at their discretion.
- Conditions
- Anemia, Nutritional Status
- Being tested
- School meals, School gardens, IFA and Deworming, Nutrition education, Women's workshops
- Keywords
- Randomized controlled trial, Schools, Adolescent nutrition, Tanzania
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School mealsOther
Daily mid-day meals sourced locally and supplemented by school gardens.
School gardensOther
A school vegetable garden to grow green leafy vegetables on school grounds.
IFA and DewormingDietary supplement
Weekly iron and folic acid supplements and annual deworming.
Nutrition educationBehavioural
Nutrition education, led by trained teachers, that will cover health, agriculture, and WASH topics.
Women's workshopsBehavioural
Community workshops that will engage mothers or female guardians in gardening, nutrition, and entrepreneurship, offering support and training for small businesses and homestead gardens.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | School meals, gardens, education, iron and folic acid supplementation, and workshops for women. Receives: Other: School meals; Other: School gardens; Dietary Supplement: IFA and Deworming; Behavioral: Nutrition education; Behavioral: Women's workshops |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Moderate to severe anemia in adolescents
Hemoglobin concentration < 110 g/L in girls and boys
Measured: Baseline and endline (approximately 12 months after baseline)
Underweight in adolescents
BMI-for-age z-score < -2 by WHO growth reference
Measured: Baseline and endline (approximately 12 months after baseline)
Secondary outcomes (6)
Anemia (any severity) in adolescents
Hemoglobin concentration < 120 g/L in girls and < 130 g/L in boys
Measured: Baseline and endline (approximately 12 months after baseline)
Overweight or obesity in adolescents
BMI-for-age z-score ≥ 1 by WHO growth reference
Measured: Baseline and endline (approximately 12 months after baseline)
Diet quality of adolescents
Diet quality as defined by the Global Diet Quality Score; a higher score indicates a better diet quality
Measured: Baseline and endline (approximately 12 months after baseline)
Diet quality of mothers
Poor diet quality as defined by the Global Diet Quality Score; a higher score indicates a better diet quality
Measured: Baseline and endline (approximately 12 months after baseline)
Household food insecurity
Defined by Household Food Insecurity Access Scale; a higher score indicates more severe food insecurity
Measured: Baseline and endline (approximately 12 months after baseline)
Women's empowerment in mothers
Defined by the Abbreviated Version of the Women's Empowerment in Agriculture Index (A-WEAI); a higher score indicates greater empowerment
Measured: Baseline and endline (approximately 12 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start19 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
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
- The study will have two arms - intervention and control. Four schools will be assigned to the intervention arm, and two schools will be assigned to the control arm. The five components of the proposed intervention package are 1) school feeding, 2) school garden, 3) nutrition education, 4) community workshops, and 5) weekly iron and folic acid (IFA) supplementation and annual deworming. 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 and the community workshop manual.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- George Mason University, 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)Dongqing Wang, PhD, MPH, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092150
- Sponsor's protocol ID
- IRB25-0043
- Acronym
- MEGA 2
- Status last verified
- May 2026
- First submitted
- 12 Jul 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Wang D, Katalambula LK, Modest AR, Ismail A, Malero A, Bray D, Cinq-Mars H, Tinkasimile A, Sando MM, Vuai S, Fawzi WW. Meals, Education, and Gardens for In-School Adolescents: A Cluster Randomized Trial of an Adolescent Nutrition Intervention Package in Tanzania. J Adolesc Health. 2024 Jul;75(1):115-126. doi: 10.1016/j.jadohealth.2024.02.032. Epub 2024 Apr 8.
PubMed 38597842
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents (MEGA) Program - MEGA 2.0
- ClinicalTrials.gov ID
- NCT07092150
- Acronym / sponsor ID
- MEGA 2 / IRB25-0043
- Conditions
- Anemia, Nutritional Status
- Keywords
- Randomized controlled trial, Schools, Adolescent nutrition, Tanzania
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- George Mason University, Africa Academy for Public Health, University of Dodoma
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Jul 2025 (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.
The overall objective of the proposed study is to determine the longer-term effectiveness and implementation of an updated school-based nutrition intervention package for reducing adolescent malnutrition. Aim 1 of the study is to determine the longer-term effectiveness of an updated intervention package on reducing adolescent malnutrition using a cluster randomized controlled trial in Dodoma, Tanzania. Four intervention schools and two control schools will be included. The intervention schools will receive an intervention package that includes school feeding, nutrition education, school vegetable garden, community workshops, and weekly iron and folic acid supplementation and annual deworming. The control schools will not receive any intervention. The intervention package will be implemented over one year. In each school, 125 adolescents aged between 14 and 17 and 125 mothers/female guardians will be enrolled. The primary outcomes will be moderate to severe anemia in adolescents and underweight in adolescents. The secondary outcomes will include anemia (any severity) and overweight/obesity in adolescents, diet quality in adolescents and mothers/female guardians, household food insecurity, and women's empowerment for mothers/female guardians. A baseline and an end-line evaluation of the outcomes will be implemented. Aim 2 of the study will be to assess the implementation of the updated intervention package by collecting quantitative and qualitative data from adolescents, mothers/female guardians, teachers, smallholder farmers, agricultural extension workers, school administrators, and governmental stakeholders. Using a convergent mixed methods approach, quantitative data (via questionnaires) and qualitative data (via semi-structured interviews and focus group discussions) will be analyzed to evaluate the implementation of the intervention package and identify its implementation barriers and facilitators.
Detailed description
This study will be a cluster-randomized controlled study and will use a mixed-methods approach to evaluate the longer-term effectiveness and implementation of an updated school-based intervention package on adolescent nutritional status in six public secondary schools in Chamwino District, Dodoma, Tanzania. Specifically:
- Aim 1 of the study is to determine the longer-term effectiveness of the updated school-based intervention package on reducing adolescent malnutrition.
- Aim 2 of the study is to assess the implementation of the updated school-based intervention package.
Study Design
This is a two-arm study comparing an intervention group to a control group. Four schools will be assigned to the intervention arm, and two schools will be assigned to the control arm. The study duration is one academic year. Baseline and endline data collection will occur at the beginning and end of the academic year, respectively. Implementation and sustainability data will be collected towards the end of the intervention period.
Intervention Arm (MEGA 2.0 Package)
The MEGA 2.0 intervention is a unified package delivered to adolescents in intervention schools, comprising five integrated components:
- School Feeding: Daily midday meals provided to all adolescents in intervention schools, meeting 60-75% of their daily energy and nutritional requirements. Meals will consist of traditional Tanzanian staples, green leafy vegetables, and will integrate local produce from farm-to-school partnerships and school gardens. School meal committees involving parents, teachers, and administrators will be established to enhance sustainability and community buy-in, with opportunities for mothers to be employed as cooks.
- School Gardens: Establishment of a vegetable garden in each intervention school. Adolescents will participate in gardening activities under the supervision of a trained focal teacher. Agricultural extension workers will provide technical support.
- Nutrition Education: Weekly sessions for adolescents led by focal teachers, covering health and nutrition, agriculture and school gardening, health benefits of vegetables, physical activity and body size, and WASH (Water, Sanitation, and Hygiene).
- Community Workshops: Bi-weekly workshops for mothers and female guardians, conducted by agricultural extension workers. Workshops will utilize school gardens as "model farms" and cover nutrition, agriculture, WASH, and entrepreneurship skills. Participants will receive seeds and gardening supplies as feasible for homestead gardens and guidance on local market entry and microfinancing schemes.
- Weekly Iron and Folic Acid (IFA) Supplementation and Annual Deworming: Weekly IFA supplements will be administered to adolescents by focal teachers during nutrition education sessions. Annual deworming with mebendazole (500 mg) will also be provided.
Control Arm
Adolescents in control schools will not receive any study interventions. They will continue with standard of care practices at secondary schools in Dodoma. Currently, standard of care in Tanzania does not include school meals or government-run school feeding programs in secondary schools. Teachers in control schools will receive a hard copy of educational materials on nutrition, agriculture, and WASH to enhance their lesson plans and a community workshop manual, to use at their discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will have two arms - intervention and control. Four schools will be assigned to the intervention arm, and two schools will be assigned to the control arm. The five components of the proposed intervention package are 1) school feeding, 2) school garden, 3) nutrition education, 4) community workshops, and 5) weekly iron and folic acid (IFA) supplementation and annual deworming. 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 and the community workshop manual.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: School meals, Other: School gardens, Dietary Supplement: IFA and Deworming, Behavioral: Nutrition education, Behavioral: Women's workshopsSchool meals, gardens, education, iron and folic acid supplementation, and workshops for women. |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (33 listed)
- Adolescent Quantitative Survey:
- Adolescent Qualitative Focus Group Discussion (FGD):
- Mother Quantitative Survey and Qualitative FGD:
- Focal Teacher Qualitative Semi-Structured Interview (SSI):
- Smallholder Farmer Qualitative SSI:
Key exclusion criteria (1 listed)
- Those who do not meet the above listed inclusion criteria.
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 mealsDaily mid-day meals sourced locally and supplemented by school gardens. | Other | Intervention |
| School gardensA school vegetable garden to grow green leafy vegetables on school grounds. | Other | Intervention |
| IFA and DewormingWeekly iron and folic acid supplements and annual deworming. | Dietary supplement | Intervention |
| Nutrition educationNutrition education, led by trained teachers, that will cover health, agriculture, and WASH topics. | Behavioural | Intervention |
| Women's workshopsCommunity workshops that will engage mothers or female guardians in gardening, nutrition, and entrepreneurship, offering support and training for small businesses and homestead gardens. | Behavioural | Intervention |
Primary outcome
1. Moderate to severe anemia in adolescents
Time frame: Baseline and endline (approximately 12 months after baseline)
Hemoglobin concentration < 110 g/L in girls and boys
Underweight in adolescents
Time frame: Baseline and endline (approximately 12 months after baseline)
BMI-for-age z-score < -2 by WHO growth reference
6 secondary outcomes
Anemia (any severity) in adolescents
Time frame: Baseline and endline (approximately 12 months after baseline)
Overweight or obesity in adolescents
Time frame: Baseline and endline (approximately 12 months after baseline)
Diet quality of adolescents
Time frame: Baseline and endline (approximately 12 months after baseline)
Diet quality of mothers
Time frame: Baseline and endline (approximately 12 months after baseline)
Household food insecurity
Time frame: Baseline and endline (approximately 12 months after baseline)
Women's empowerment in mothers
Time frame: Baseline and endline (approximately 12 months after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 38597842Wang D, Katalambula LK, Modest AR, Ismail A, Malero A, Bray D, Cinq-Mars H, Tinkasimile A, Sando MM, Vuai S, Fawzi WW. Meals, Education, and Gardens for In-School Adolescents: A Cluster Randomized Trial of an Adolescent Nutrition Intervention Package in Tanzania. J Adolesc Health. 2024 Jul;75(1):115-126. doi: 10.1016/j.jadohealth.2024.02.032. Epub 2024 Apr 8.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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)
Dongqing Wang, PhD, MPH principal investigator
George Mason University
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 meals, School gardens and IFA and Deworming in people with Anemia and Nutritional Status, 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 33 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
1. Moderate to severe anemia in adolescents (time frame: Baseline and endline (approximately 12 months after baseline)). The study lists 2 primary outcomes in all. 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 NCT07092150, 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 18 May 2026.