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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03607084
Other study ID # IRB15-1539
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 17, 2015
Est. completion date July 28, 2016

Study information

Verified date July 2018
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

While school-aged children in low- and middle-income countries remain highly exposed to acute infections, programs targeting this age group remain limited in scale and scope. In this study, we evaluate the impact of a new and comprehensive primary school-based health intervention program on student health outcomes and academic performance in Lusaka, Zambia. The intervention involved the training of teachers to become school health workers and the provision of vitamin A supplementation and deworming medication on a bi-annual basis. Teachers in intervention schools were trained to deliver health lessons and to refer sick students to care. This study is designed as a prospective matched control study. Students from the seven intervention schools are matched with students from control schools.


Recruitment information / eligibility

Status Completed
Enrollment 614
Est. completion date July 28, 2016
Est. primary completion date July 28, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
School Health Worker Program
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Harvard School of Public Health Healthy Kids/Brighter Future

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in weight Calculate body mass index (BMI)-for-age z-scores using the World Health Organization AnthroPlus Software macro for Stata. Thinness and overweightness are defined respectively as: BMI-for-age below -2 SD and as BMI-for-age above 1 standard deviation. Baseline, 6 months, and one-year follow-up
Secondary Change in height Calculate standardized height-for-age (HAZ) z-scores using the World Health Organization AnthroPlus Software macro for Stata. Stunting was defined as HAZ below -2 standard deviation. Baseline, 6 months, and one-year follow-up
Secondary Change in health knowledge Calculate the percentage of correct answers on 11-question quiz on various health topics. Baseline, 6 months, and one-year follow-up
Secondary Change in school attendance Calculate percentage of students who missed one or more days from school in the past two weeks. Baseline, 6 months, and one-year follow-up
Secondary Change in academic performance Students report on their own school performance and academic performance is verified by term marks. Baseline, 6 months, and one-year follow-up
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