NCT03607084

Brief Summary

This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

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

Study Start

First participant enrolled

June 17, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

July 11, 2018

Last Update Submit

July 30, 2018

Conditions

Keywords

school-aged childrenschool-based health programZambiachild and adolescent health

Outcome Measures

Primary Outcomes (1)

  • Change in prevalence of acute disease

    Students report on the presence of 14 systemic, genitourinary, respiratory, and gastrointestinal illnesses in the past two week. Acute illnesses are combined into a summary index of morbidity.

    Baseline, 6 months, and one-year follow-up

Secondary Outcomes (5)

  • Change in weight

    Baseline, 6 months, and one-year follow-up

  • Change in height

    Baseline, 6 months, and one-year follow-up

  • Change in health knowledge

    Baseline, 6 months, and one-year follow-up

  • Change in school attendance

    Baseline, 6 months, and one-year follow-up

  • Change in academic performance

    Baseline, 6 months, and one-year follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group receives a school health program that has two components: the training of selected teachers to become school Health Workers and bi-annual health screenings of all students.

Behavioral: School Health Worker Program

Control

NO INTERVENTION

The control group receives regular school programming.

Interventions

The intervention trains selected teachers to deliver health lessons to students, perform basic first aid, recognize common illnesses, refer student to skilled medical attention when needed. The intervention provides schools with basic medical supplies including pain relief medication, thermometers, bandages, antiseptics, and oral rehydration solution. Vitamin A supplementation and presumptive deworming medication are administered to students during biannual health screenings.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children attending one of the 14 schools in the study.

You may not qualify if:

  • Children not attending one of the 14 schools in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wei D, Brigell R, Khadka A, Perales N, Fink G. Comprehensive school-based health programs to improve child and adolescent health: Evidence from Zambia. PLoS One. 2019 May 31;14(5):e0217893. doi: 10.1371/journal.pone.0217893. eCollection 2019.

MeSH Terms

Conditions

Acute Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor of Global Health

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 31, 2018

Study Start

June 17, 2015

Primary Completion

July 28, 2016

Study Completion

July 28, 2016

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share