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

NCT07092150 | Not Yet Recruiting

• 1 other identifier: IRB25-0043
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Nutritional Status

Keywords

Randomized controlled trial; Schools; Adolescent nutrition; Tanzania

Outcome Measures

Primary Outcomes (2)

• 1. Moderate to severe anemia in adolescents

  Hemoglobin concentration \< 110 g/L in girls and boys

  Baseline and endline (approximately 12 months after baseline)

• Underweight in adolescents

  BMI-for-age z-score \< -2 by WHO growth reference

  Baseline and endline (approximately 12 months after baseline)

Secondary Outcomes (6)

• Anemia (any severity) in adolescents

  Baseline and endline (approximately 12 months after baseline)

• Overweight or obesity in adolescents

  Baseline and endline (approximately 12 months after baseline)

• Diet quality of adolescents

  Baseline and endline (approximately 12 months after baseline)

• Diet quality of mothers

  Baseline and endline (approximately 12 months after baseline)

• Household food insecurity

  Baseline and endline (approximately 12 months after baseline)

Study Arms (2)

Intervention

EXPERIMENTAL

School meals, gardens, education, iron and folic acid supplementation, and workshops for women.

Other: School meals; Other: School gardens; Dietary Supplement: IFA and Deworming; Behavioral: Nutrition education; Behavioral: Women's workshops

Control

NO INTERVENTION

Standard of care

Interventions

School meals OTHER

Daily mid-day meals sourced locally and supplemented by school gardens.

Intervention

School gardens OTHER

A school vegetable garden to grow green leafy vegetables on school grounds.

Intervention

IFA and Deworming DIETARY_SUPPLEMENT

Weekly iron and folic acid supplements and annual deworming.

Intervention

Nutrition education BEHAVIORAL

Nutrition education, led by trained teachers, that will cover health, agriculture, and WASH topics.

Intervention

Women's workshops BEHAVIORAL

Community workshops that will engage mothers or female guardians in gardening, nutrition, and entrepreneurship, offering support and training for small businesses and homestead gardens.

Intervention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Gender Eligibility Details: Selection of adolescents will not be based on gender. However, for parents and guardians, only mothers and female guardians will be invited to participate.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• George Mason University: collaborator
• Africa Academy for Public Health: collaborator
• University of Dodoma: collaborator

Study Sites (1)

University of Dodoma

Dodoma, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 38597842 BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Wafaie W Fawzi, MBBS, MPH, MS, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Dongqing Wang, PhD, MPH

  George Mason University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wafaie W Fawzi, MBBS, MPH, MS, DrPH

CONTACT

+1-617-432-2086; mina@hsph.harvard.edu

Dongqing Wang, PhD, MPH

CONTACT

+1-703-993-3578; dwang25@gmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Epidemiology, and Global Health

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)