Empowering Adolescents to Lead Change Using Health Data

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Behavioral interventions targeting multiple risk behaviors as well as protective factors; Other: School-level interventions targeting the school environment and system

Detailed Description

The objective of this study is to generate health information through school surveys and use this information directly and locally, involving adolescents, to change policies and plan programmes to improve health.

The study is carried out in secondary cities of four low- and middle income countries, including Sekondi-Takoradi, Ghana; Jaipur, India; Spanish Town, Jamaica; and Fez, Morocco.

In each of the four cities, 30 schools are randomly selected. Baseline surveys will be conducted to assess (1) 13-17 year old student's health behaviours using the Global School-based Student Health Survey (GSHS); and (2) health policies and practices in the selected schools using the Global School Health Policies and Practices Study (G-SHPPS). Additionally, the physical activity module of the GSHS questionnaire will be validated against objective measurement devices in one randomly selected class of 15 randomly selected schools.

Schools will be randomly allocated to the intervention (15 schools) or control arm (15 schools) of the study. The intervention group will participate in interactive workshops using the Global Accelerated Action for the Health of Adolescents (Global AA-HA!) approach and the framework of Making every school a health-promoting school to:

1. Identify adolescent health needs through exploring the collected data;
2. Assess policies and practices already in place;
3. Identify gaps and needs for action to improve health. Students, teachers and local authorities will propose and prioritize policy and programme solutions from menus of effective interventions for school-, community- or city-level implementation, supported by the Ministries of Health and Education and WHO.

Repeat GSHS and G-SHPPS surveys will be conducted two years later in all schools to assess effectiveness of the interventions.

• Study Type: Interventional
• Enrollment (Estimated): 12612
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Regina Guthold, PhD; Phone Number: +41 79 621 5691; Email: gutholdr@who.int
• Study Contact Backup: Name: Leanne M Riley, MSc; Phone Number: +41 22 791 4319; Email: rileyl@who.int

Study Locations

• Ghana
  • Sekondi-Takoradi, Ghana
    • Enrolling by invitation
    • WHO
• India
  • Jaipur, India
    • Enrolling by invitation
    • WHO
• Jamaica
  • Spanish Town, Jamaica
    • Recruiting
    • WHO
    • Sub-Investigator: Dolores Ondarsuhu
    • Contact: Uki Atkinson; Email: uatkinson@ncda.org.jm
    • Principal Investigator: Uki Atkinson
    • Sub-Investigator: Sonja Caffe
    • Sub-Investigator: Roberta De Betania Caixeta
• Morocco
  • Fez, Morocco
    • Recruiting
    • WHO
    • Contact: Tahar Ouaourir; Email: o_tahar2011@yahoo.fr
    • Principal Investigator: Tahar Ouaourir
    • Sub-Investigator: Hafid Hachri
    • Sub-Investigator: Heba Fouad
    • Sub-Investigator: Khalid Siddeeg
• Switzerland
  • Geneva, Switzerland, 1211
    • Enrolling by invitation
    • WHO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• School going
• Aged 13-17 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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 factors; 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.; Other: School-level interventions targeting the school environment and system; 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
No Intervention: Control arm; The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
School-level policies and practices	School-level outcomes related to the following: school policies and resources, school governance and leadership, school and community partnerships, school curriculum, school social-emotional environment, school physical environment, school health services measured with the Global School Health Policies and Practices Study (G-SHPPS)	Two years

Collaborators and Investigators

• Sponsor: World Health Organization
• Collaborators: University of Bern; University of Wollongong; Fondation Botnar
• Investigators: Principal Investigator: Regina Guthold, PhD, World Health Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: risk factors; students; schools; adolescent health; protective factors; school health services
• Other Study ID Numbers: ERC.0003397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The documents above will become available after the study protocol has been published in a scientific journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No