- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03607084
School-based Health Programs on Children's Wellbeing in Lusaka, Zambia
July 30, 2018 updated by: Günther Fink, Harvard School of Public Health (HSPH)
Evaluating the Impact of School-based Health Programs on Children's Well-being and Academic Performance
This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
614
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
No Intervention: Control
The control group receives regular school programming.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in prevalence of acute disease
Time Frame: Baseline, 6 months, and one-year follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: Baseline, 6 months, and one-year follow-up
|
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
|
|
Change in height
Time Frame: Baseline, 6 months, and one-year follow-up
|
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
|
|
Change in health knowledge
Time Frame: Baseline, 6 months, and one-year follow-up
|
Calculate the percentage of correct answers on 11-question quiz on various health topics.
|
Baseline, 6 months, and one-year follow-up
|
|
Change in school attendance
Time Frame: Baseline, 6 months, and one-year follow-up
|
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
|
|
Change in academic performance
Time Frame: Baseline, 6 months, and one-year follow-up
|
Students report on their own school performance and academic performance is verified by term marks.
|
Baseline, 6 months, and one-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 17, 2015
Primary Completion (Actual)
July 28, 2016
Study Completion (Actual)
July 28, 2016
Study Registration Dates
First Submitted
July 11, 2018
First Submitted That Met QC Criteria
July 30, 2018
First Posted (Actual)
July 31, 2018
Study Record Updates
Last Update Posted (Actual)
July 31, 2018
Last Update Submitted That Met QC Criteria
July 30, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB15-1539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.