NCT03423615

Brief Summary

School-aged children in low and middle-income countries (LMIC) face significant challenges to their health and development which contribute to poor academic achievement. Multi-component comprehensive school health programs guided by the World Health Organization's (WHO) Health Promoting Schools (HPS) framework have been shown to positively impact health outcomes. Such programs are implemented widely throughout the world. However, in LMIC the scope and reach of school health programs are limited by human resource constraints. A key challenge to effective implementation has been the identification of effective delivery agents. A potential alternative approach is to leverage existing community members as lay fieldworkers for the delivery of school health promotion. Our hypothesis is that lay-fieldworkers can effectively implement comprehensive school health programs in resource-constrained primary schools. This hypothesis will be tested by retrospectively analyzing data obtained during a 5-year pilot of a school health program (CHHIP) in rural primary schools of the Darjeeling Himalayas of India.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,909

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

February 6, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 20, 2018

Last Update Submit

January 30, 2018

Conditions

Keywords

School Health ServicesHealth EducationPrimary SchoolsRepublic of India

Outcome Measures

Primary Outcomes (1)

  • Diarrhea incidence

    Diarrheal incidence was assessed by verbal parental recall based on previous 14-days.

    March, July, and November of each academic school year through the duration of the study (up to 5-years)

Secondary Outcomes (1)

  • Health Knowledge

    Baseline and week 32 of each academic year through the duration of the study (up to 5-years)

Other Outcomes (2)

  • Coverage rates

    At the time of intervention delivery

  • Fidelity

    At the time of intervention delivery

Study Arms (2)

CHHIP Arm

EXPERIMENTAL

All enrolled students in schools in the CHHIP Arm were eligible to receive the CHHIP intervention. The CHHIP intervention was delivered by lay fieldworkers (SHAs). Intervention activities included: 1. Health Education: activity-based curriculum with lessons delivered once per week. Units include hygiene, nutrition, safety, disease prevention\& management, and social, emotional, and behavior development. 2. Basic Primary Health Services: school-based treatment including deworming and iron supplementation; screening and referral programs including growth monitoring, well-child exam, vision screening, epilepsy screening, and oral health; psychosocial and counseling support for students with atypical behaviors. 3. Health School Environment: improvements to physical infrastructure including latrines and water systems; modeling of positive behavior reinforcement, inclusive learning environment, and avoidance of corporal punishment.

Behavioral: Comprehensive Health & Hygiene Improvement Program (CHHIP)

Comparison Arm

NO INTERVENTION

All enrolled students in schools in the Comparison Arm received school health activities as were routinely available in their school, through their curriculum, or through special events.

Interventions

CHHIP is an intense, multi-component holistic school health program based on the WHO Health Promoting School framework and designed for implementation by lay fieldworkers.

CHHIP Arm

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Three geographic regions representative of rural Darjeeling were identified and all primary schools in these regions were considered eligible for participation in the intervention. A convenience sample of 22 schools were pragmatically selected.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Matergia M, Ferrarone P, Khan Y, Matergia DW, Giri P, Thapa S, Simoes EAF. Lay Field-worker-Led School Health Program for Primary Schools in Low- and Middle-Income Countries. Pediatrics. 2019 Apr;143(4):e20180975. doi: 10.1542/peds.2018-0975. Epub 2019 Mar 14.

MeSH Terms

Conditions

DiarrheaHealth Education

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michael Matergia, MD

    Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: We will use a stepped-wedge cluster controlled model to reflect the pragmatic enrollment and crossover of schools between intervention arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 6, 2018

Study Start

February 1, 2012

Primary Completion

November 15, 2016

Study Completion

December 31, 2016

Last Updated

February 6, 2018

Record last verified: 2018-01