Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-26 @ 4:50 AM
Study NCT ID:
NCT07092150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents Program
Sponsor:
Harvard School of Public Health (HSPH)
Organization:
Study Overview
Official Title:
Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents (MEGA) Program - MEGA 2.0
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEGA 2
Brief 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. 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: