Empowering Adolescents to Lead Change Using Health Data

August 6, 2024 updated by: Regina Guthold, World Health Organization
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12612

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Principal Investigator:
          • Uki Atkinson
        • Sub-Investigator:
          • Sonja Caffe
        • Sub-Investigator:
          • Roberta De Betania Caixeta
  • Morocco
      • Fez, Morocco
        • Recruiting
        • WHO
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol use
Time Frame: Two years
Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS)
Two years
Dietary behaviors
Time Frame: Two years
Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS)
Two years
Drug use
Time Frame: Two years
Self-reported drug use measured with the Global School-based Student Health Survey (GSHS)
Two years
Hygiene
Time Frame: Two years
Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS)
Two years
Mental health
Time Frame: Two years
Self-reported mental health measured with the Global School-based Student Health Survey (GSHS)
Two years
Physical activity
Time Frame: Two years
Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS)
Two years
Protective factors
Time Frame: Two years
Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS)
Two years
Sexual behaviors
Time Frame: Two years
Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS)
Two years
Tobacco use
Time Frame: Two years
Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS)
Two years
Violence and unintentional injury
Time Frame: Two years
Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS)
Two years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
School-level policies and practices
Time Frame: Two years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
World Health Organization

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern
University of Wollongong
Fondation Botnar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regina Guthold, PhD, World Health Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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