NCT04963426

Brief Summary

This study is a cluster randomized trial carried out in schools of secondary cities of four low- and middle income countries. Baseline surveys in 30 randomly selected schools will assess the health behaviours of 13-17 year old students as well as school policies and practices. The intervention arm (15 schools) will use the baseline information to develop a package of actions in collaboration with students, teachers, and local authorities that will subsequently be implemented an monitored over two years. Follow-up surveys to evaluate the effectiveness of the implemented actions will be conducted after two years in all 30 previously selected schools.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
12,612

participants targeted

Target at P75+ for not_applicable healthy

Timeline
8mo left

Started Jan 2022

Longer than P75 for not_applicable healthy

Geographic Reach
5 countries

5 active sites

Status
recruiting

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 Progress87%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

July 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4.5 years

First QC Date

July 5, 2021

Last Update Submit

August 6, 2024

Conditions

Keywords

adolescent healthstudentsschoolsrisk factorsprotective factorsschool health services

Outcome Measures

Primary Outcomes (10)

  • Alcohol use

    Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Dietary behaviors

    Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Drug use

    Self-reported drug use measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Hygiene

    Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Mental health

    Self-reported mental health measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Physical activity

    Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Protective factors

    Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Sexual behaviors

    Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Tobacco use

    Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS)

    Two years

  • Violence and unintentional injury

    Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS)

    Two years

Other Outcomes (1)

  • School-level policies and practices

    Two years

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention consists of interactive workshops that will be facilitated by WHO and trained local personnel and involve students, teachers and local authorities. In the workshops, the Global Accelerated Action for the Health of Adolescents (Global AA-HA!) approach will be used to: * identify adolescent health needs through exploring the collected baseline data; * assess policies and practices already in place; * identify gaps and needs for action to improve health. A menu of actions will be identified, prioritized, implemented and monitored.

Behavioral: Behavioral interventions targeting multiple risk behaviors as well as protective factorsOther: School-level interventions targeting the school environment and system

Control arm

NO INTERVENTION

The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys.

Interventions

Depending on the baseline data and prioritization of actions, behavioral interventions related to the following topics will be implemented: alcohol use, dietary behaviors, drug use, hygiene, mental health, physical activity, protective factors, sexual behaviors, tobacco use, violence and unintentional injury.

Intervention arm

Depending on the baseline data and prioritization of actions, and based on the Global Standards for Health Promoting Schools, school-level interventions related to the following will be implemented: school policies and resources, school governance and leadership, school and community partnerships, school curriculum, school social-emotional environment, school physical environment, school health services

Intervention arm

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • School going
  • Aged 13-17 years

You may not qualify if:

  • Not going to school
  • Outside the age range 13-17 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

WHO

Sekondi-Takoradi, Ghana

ENROLLING BY INVITATION

WHO

Jaipur, India

ENROLLING BY INVITATION

WHO

Spanish Town, Jamaica

RECRUITING

WHO

Fes, Morocco

RECRUITING

WHO

Geneva, 1211, Switzerland

ENROLLING BY INVITATION

Related Publications (1)

  • Guthold R, Kann L, Bhatti L, Abduvahobov P, Ansong J, Atkinson U, Baltag V, Caffe S, Caixeta R, Diallo CB, Fouad H, Haddad S, Hachri H, Jaggi JA, Joshi P, Karna P, Louazani SA, Mbola Mbassi S, Mehta R, Mudgal Y, Nigg CR, Okely AD, Ondarsuhu D, Ouaourir T, Trhari FZ, Riley LM. Effectiveness of a participatory approach to develop school health interventions in four low resource cities: study protocol of the 'empowering adolescents to lead change using health data' cluster randomised controlled trial. BMJ Open. 2023 Jul 5;13(7):e071353. doi: 10.1136/bmjopen-2022-071353.

MeSH Terms

Interventions

Protective FactorsDrug Delivery Systems

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public HealthDrug TherapyTherapeutics

Study Officials

  • Regina Guthold, PhD

    World Health Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Guthold, PhD

CONTACT

Leanne M Riley, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 15, 2021

Study Start

January 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

After a two year window following completion of data collection, the GSHS and G-SHPPS data will be released as public access datasets, including in the WHO NCD microdata repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The documents above will become available after the study protocol has been published in a scientific journal.

Locations