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Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents Program

Study acronym: MEGA 2
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jan 2026 to Jan 19, 2026
    • Site contact updated
    v3
  2. Notable Primary completion date: Jun 2026 to Jun 2027
    • Start date: Jul 2025 to Jan 2026
    • Study completion date: Jun 2026 to Jan 2028
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07092150
Lead Sponsor Harvard School of Public Health (HSPH)
Collaborators: George Mason University, Africa Academy for Public Health, University of Dodoma
Conditions
(from sponsor)
Anemia, Nutritional Status
Related terms Anemia
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov