Empowering Adolescents to Lead Change Using Health Data

Healthy Clinical Trial

Official title:

Empowering Adolescents to Lead Change Using Health Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963426
• Other study ID #: ERC.0003397
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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