NCT04788303

Brief Summary

This purpose of this study is to assess effects of a comprehensive, school-based nutrition intervention package on anemia status, anthropometric indicators, school performance/attendance, and development indicators among adolescents, and the knowledge, attitudes, and practices of nutrition, agriculture, and WASH among parents, in Tanzania.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 20, 2021

Last Update Submit

May 1, 2023

Conditions

Keywords

AnemiaSchool gardenSchool lunchNutritionAdolescent health

Outcome Measures

Primary Outcomes (1)

  • Anemia status

    Anemia status will be defined using the diagnostic criteria by the World Health Organization. Specifically, the following criteria will be used: \< 12 g/dL for adolescent girls and adolescent boys aged 14 yrs and \< 13 g/dL for adolescent boys aged 15-19 yrs

    Up to one year

Secondary Outcomes (13)

  • Height

    Up to one year

  • Weight

    Up to one year.

  • BMI

    Up to one year

  • Knowledge of adolescents regarding nutrition and dietary intake

    Up to one year

  • Attitudes of adolescents regarding nutrition and dietary intake

    Up to one year

  • +8 more secondary outcomes

Study Arms (3)

Full intervention

ACTIVE COMPARATOR

Full intervention: school meal, garden, education, and community workshops

Other: School meal, garden, education, and community workshops

Partial intervention

ACTIVE COMPARATOR

Partial intervention: garden, education, and community workshops

Other: Garden, education, and community workshops

Control

NO INTERVENTION

Control: standard of care

Interventions

School meal: midday meal provided at intervention schools School garden: garden used to grow crops (which will be used to supplement the school meal in the full intervention schools) Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.

Also known as: Full intervention package
Full intervention

School garden: garden used to grow crops Education: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum Community workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.

Also known as: Partial intervention package
Partial intervention

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents:
  • Adolescents aged 14-17 years
  • Enrolled in secondary school forms 1 or 2 at study initiation
  • Member of one of the selected classes in a participating school
  • Consent provided by the parent
  • Assent provided by the adolescent
  • Fluent in Swahili or English
  • Parents:
  • Parent or guardian of participating adolescent
  • Provides informed consent
  • Fluent in Swahili or English
  • Teachers:
  • Teacher facilitating the meal, garden, and/or education interventions
  • Provides informed consent
  • Fluent in Swahili or English

You may not qualify if:

  • Adolescents:
  • No informed consent from parent/guardian or assent from adolescent
  • Parents:
  • No informed consent
  • Teachers:
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dodoma

Dodoma, Tanzania

Location

Related Publications (1)

  • Wang D, Katalambula LK, Modest AR, Young T, Ismail A, Mwanyika-Sando M, Tinkasimile A, Mosha D, Malero A, Vuai S, Fawzi WW. Meals, Education, and Gardens for In-School Adolescents (MEGA): study protocol for a cluster randomised trial of an integrated adolescent nutrition intervention in Dodoma, Tanzania. BMJ Open. 2022 Jul 7;12(7):e062085. doi: 10.1136/bmjopen-2022-062085.

MeSH Terms

Conditions

Anemia

Interventions

GardensEducational Status

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AgricultureTechnology, Industry, and AgricultureNon-Medical Public and Private FacilitiesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Wafaie W Fawzi, MBBS, MPH, MS, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Six schools will be randomly assigned to receive the full intervention (school meal, garden, and education), partial intervention (garden and education), or control (standard of care). Community workshops will also be provided to parents of adolescents in full and partial intervention schools.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition, Epidemiology, and Global Health

Study Record Dates

First Submitted

February 20, 2021

First Posted

March 9, 2021

Study Start

January 24, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations