University of Dodoma
Dodoma, Tanzania
NCT Number: NCT07092150
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.
This study is active but is not currently recruiting participants.
Notify Me14 year–17 year
All sexes
Interventional
Not applicable
Dodoma, Tanzania
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:
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Those who do not meet the above listed inclusion criteria.
Daily mid-day meals sourced locally and supplemented by school gardens.
A school vegetable garden to grow green leafy vegetables on school grounds.
Weekly iron and folic acid supplements and annual deworming.
Nutrition education, led by trained teachers, that will cover health, agriculture, and WASH topics.
Community workshops that will engage mothers or female guardians in gardening, nutrition, and entrepreneurship, offering support and training for small businesses and homestead gardens.
Time frame: Baseline and endline (approximately 12 months after baseline)
Hemoglobin concentration < 110 g/L in girls and boys
Time frame: Baseline and endline (approximately 12 months after baseline)
BMI-for-age z-score < -2 by WHO growth reference
Time frame: Baseline and endline (approximately 12 months after baseline)
Hemoglobin concentration < 120 g/L in girls and < 130 g/L in boys
Time frame: Baseline and endline (approximately 12 months after baseline)
BMI-for-age z-score ≥ 1 by WHO growth reference
Time frame: Baseline and endline (approximately 12 months after baseline)
Diet quality as defined by the Global Diet Quality Score; a higher score indicates a better diet quality
Time frame: Baseline and endline (approximately 12 months after baseline)
Poor diet quality as defined by the Global Diet Quality Score; a higher score indicates a better diet quality
Time frame: Baseline and endline (approximately 12 months after baseline)
Defined by Household Food Insecurity Access Scale; a higher score indicates more severe food insecurity
Time frame: Baseline and endline (approximately 12 months after baseline)
Defined by the Abbreviated Version of the Women's Empowerment in Agriculture Index (A-WEAI); a higher score indicates greater empowerment
Harvard School of Public Health (HSPH)
Other
Long-term Effectiveness and Implementation of the Meals, Education, and Gardens for In-School Adolescents (MEGA) Program - MEGA 2.0
Acronym: MEGA 2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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