Empowering Adolescents to Lead Change Using Health Data

NCT ID: NCT04963426

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Behavioral interventions targeting multiple risk behaviors as well as protective factors

Intervention Type BEHAVIORAL

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.

School-level interventions targeting the school environment and system

Intervention Type OTHER

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

Control arm

The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* School going
* Aged 13-17 years

Exclusion Criteria

* Not going to school
* Outside the age range 13-17 years
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Botnar

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

University of Wollongong

OTHER

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Regina Guthold

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Regina Guthold, PhD

Role: PRINCIPAL_INVESTIGATOR

World Health Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WHO

Sekondi-Takoradi, , Ghana

Site Status ENROLLING_BY_INVITATION

WHO

Jaipur, , India

Site Status ENROLLING_BY_INVITATION

WHO

Spanish Town, , Jamaica

Site Status RECRUITING

WHO

Fes, , Morocco

Site Status RECRUITING

WHO

Geneva, , Switzerland

Site Status ENROLLING_BY_INVITATION

Countries

Review the countries where the study has at least one active or historical site.

Ghana India Jamaica Morocco Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Regina Guthold, PhD

Role: CONTACT

+41 79 621 5691

Leanne M Riley, MSc

Role: CONTACT

+41 22 791 4319

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Uki Atkinson

Role: primary

Tahar Ouaourir

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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 protocol of the 'empowering adolescents to lead change using health data' cluster randomised controlled trial. BMJ Open. 2023 Jul 5;13(7):e071353. doi: 10.1136/bmjopen-2022-071353.

Reference Type DERIVED
PMID: 37407059 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERC.0003397

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Parents Advancing Toddler Health
NCT04824989 UNKNOWN NA
Evaluating the Hope@School Prevention Program
NCT06359262 NOT_YET_RECRUITING NA