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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04963426
Other study ID # ERC.0003397
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date January 2026

Study information

Verified date December 2022
Source World Health Organization
Contact Regina Guthold, PhD
Phone +41 79 621 5691
Email gutholdr@who.int
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12612
Est. completion date January 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - School going - Aged 13-17 years Exclusion Criteria: - Not going to school - Outside the age range 13-17 years

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Ghana WHO Sekondi-Takoradi
India WHO Jaipur
Jamaica WHO Spanish Town
Morocco WHO Fez
Switzerland WHO Geneva

Sponsors (4)

Lead Sponsor Collaborator
World Health Organization Fondation Botnar, University of Bern, University of Wollongong

Countries where clinical trial is conducted

Ghana,  India,  Jamaica,  Morocco,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary Alcohol use Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Dietary behaviors Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Drug use Self-reported drug use measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Hygiene Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Mental health Self-reported mental health measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Physical activity Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Protective factors Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Sexual behaviors Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Tobacco use Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS) Two years
Primary Violence and unintentional injury Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS) Two years
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