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Recruiting NCT04963426

Empowering Adolescents to Lead Change Using Health Data

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral interventions targeting multiple risk behaviors as well as protective factors, School-level interventions targeting the school environment and system.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana, India, Jamaica, Morocco, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Alcohol use [Time frame: Two years]
  • Dietary behaviors [Time frame: Two years]
  • Drug use [Time frame: Two years]
  • Hygiene [Time frame: Two years]
  • Mental health [Time frame: Two years]
  • Physical activity [Time frame: Two years]
  • Protective factors [Time frame: Two years]
  • Sexual behaviors [Time frame: Two years]
  • Tobacco use [Time frame: Two years]
  • Violence and unintentional injury [Time frame: Two years]

Eligibility criteria

Inclusion criteria

  • School going
  • Aged 13-17 years

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Ghana · 1 center
  • WHO — Sekondi-Takoradi
India · 1 center
  • WHO — Jaipur
Jamaica · 1 center
  • WHO — Spanish Town
Morocco · 1 center
  • WHO — Fes
Switzerland · 1 center
  • WHO — Geneva

Publications

  • 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 protoco PMID 37407059

Identifiers

NCT: NCT04963426 · ERC.0003397

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗