Acute DiseaseNCT03607084
School-based Health Programs on Children's Wellbeing in Lusaka, Zambia
A study testing School Health Worker Program in people with Acute Disease and Morbidity, run by Harvard School of Public Health (HSPH).
Trial summary
This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Disease, Morbidity
- What is being tested?
- School Health Worker Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2015to 28 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children attending one of the 14 schools in the study.
Who cannot join
- Children not attending one of the 14 schools in the study.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Disease, Morbidity
- Being tested
- School Health Worker Program
- Keywords
- school-aged children, school-based health program, Zambia, child and adolescent health
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School Health Worker ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: School Health Worker Program |
| Control | No intervention | The control group receives regular school programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and one-year follow-up
Secondary outcomes (5)
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.
Measured: Baseline, 6 months, and one-year follow-up
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.
Measured: Baseline, 6 months, and one-year follow-up
Change in health knowledge
Calculate the percentage of correct answers on 11-question quiz on various health topics.
Measured: Baseline, 6 months, and one-year follow-up
Change in school attendance
Calculate percentage of students who missed one or more days from school in the past two weeks.
Measured: Baseline, 6 months, and one-year follow-up
Change in academic performance
Students report on their own school performance and academic performance is verified by term marks.
Measured: Baseline, 6 months, and one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start17 Jun 2015
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Kids/Brighter Future
- Responsible party
- Principal investigator, Günther Fink, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607084
- Sponsor's protocol ID
- IRB15-1539
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31150484
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of School-based Health Programs on Children's Well-being and Academic Performance
- ClinicalTrials.gov ID
- NCT03607084
- Acronym / sponsor ID
- IRB15-1539
- Conditions
- Acute Disease, Morbidity
- Keywords
- school-aged children, school-based health program, Zambia, child and adolescent health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Healthy Kids/Brighter Future
- Study start
- 17 Jun 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the impact of a new and comprehensive school-based health program implemented in Lusaka, Zambia.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: School Health Worker ProgramThe 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. |
| Control | No intervention | –The control group receives regular school programming. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children attending one of the 14 schools in the study.
Key exclusion criteria (1 listed)
- Children not attending one of the 14 schools in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School Health Worker ProgramThe 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. | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
Change in weight
Time frame: Baseline, 6 months, and one-year follow-up
Change in height
Time frame: Baseline, 6 months, and one-year follow-up
Change in health knowledge
Time frame: Baseline, 6 months, and one-year follow-up
Change in school attendance
Time frame: Baseline, 6 months, and one-year follow-up
Change in academic performance
Time frame: Baseline, 6 months, and one-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 31150484Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing School Health Worker Program in people with Acute Disease and Morbidity, run by Harvard School of Public Health (HSPH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence of acute disease (time frame: Baseline, 6 months, and one-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.