HealthyNCT04963426
Empowering Adolescents to Lead Change Using Health Data
A study testing Behavioral interventions targeting multiple risk behaviors as well as protective factors and School-level interventions targeting the school environment and system in people with Healthy, run by World Health Organization at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Healthy
- What is being tested?
- Behavioral interventions targeting multiple risk behaviors as well as protective factors and School-level interventions targeting the school environment and system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,612 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jan 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School going
- Aged 13-17 years
Who cannot join
- Not going to school
- Outside the age range 13-17 years
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Jamaica1 site, 1 recruiting
- Recruiting
WHO
Spanish Town
Uki Atkinson, uatkinson@ncda.org.jm
Uki Atkinson
Morocco1 site, 1 recruiting
- Recruiting
WHO
Fes
Tahar Ouaourir, o_tahar2011@yahoo.fr
Tahar Ouaourir
About this study
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.
Read the 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:
- Identify adolescent health needs through exploring the collected data;
- Assess policies and practices already in place;
- 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
- Healthy
- Being tested
- Behavioral interventions targeting multiple risk behaviors as well as protective factors, School-level interventions targeting the school environment and system
- Keywords
- adolescent health, students, schools, risk factors, protective factors, school health services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventions targeting multiple risk behaviors as well as protective factorsBehavioural
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 systemOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Behavioral interventions targeting multiple risk behaviors as well as protective factors; Other: School-level interventions targeting the school environment and system |
| Control arm | No intervention | The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Dietary behaviors
Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Drug use
Self-reported drug use measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Hygiene
Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Mental health
Self-reported mental health measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Physical activity
Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Protective factors
Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Sexual behaviors
Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Tobacco use
Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Violence and unintentional injury
Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2022
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12,612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Botnar, University of Bern, University of Wollongong
- Responsible party
- Principal investigator, Regina Guthold, World Health Organization
- Investigators
- Regina Guthold, PhD, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963426
- Sponsor's protocol ID
- ERC.0003397
- Status last verified
- Aug 2024
- First submitted
- 5 Jul 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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 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.
PubMed 37407059
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Adolescents to Lead Change Using Health Data
- ClinicalTrials.gov ID
- NCT04963426
- Acronym / sponsor ID
- ERC.0003397
- Conditions
- Healthy
- Keywords
- adolescent health, students, schools, risk factors, protective factors, school health services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,612 participants (estimated)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Collaborators
- Fondation Botnar, University of Bern, University of Wollongong
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify adolescent health needs through exploring the collected data;
- Assess policies and practices already in place;
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Behavioral interventions targeting multiple risk behaviors as well as protective factors, Other: School-level interventions targeting the school environment and systemThe 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. |
| Control arm | No intervention | –The schools in the control arm will not participate in any intervention and continue 'as usual' after the baseline surveys. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School going
- Aged 13-17 years
Key exclusion criteria (2 listed)
- Not going to school
- Outside the age range 13-17 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral interventions targeting multiple risk behaviors as well as protective factorsDepending 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. | Behavioural | Intervention arm |
| School-level interventions targeting the school environment and systemDepending 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 | Other | Intervention arm |
Primary outcome
Alcohol use
Time frame: Two years
Self-reported alcohol use measured with the Global School-based Student Health Survey (GSHS)
Dietary behaviors
Time frame: Two years
Self-reported dietary behaviors measured with the Global School-based Student Health Survey (GSHS)
Drug use
Time frame: Two years
Self-reported drug use measured with the Global School-based Student Health Survey (GSHS)
Hygiene
Time frame: Two years
Self-reported hygiene measured with the Global School-based Student Health Survey (GSHS)
Mental health
Time frame: Two years
Self-reported mental health measured with the Global School-based Student Health Survey (GSHS)
Physical activity
Time frame: Two years
Self-reported physical activity measured with the Global School-based Student Health Survey (GSHS)
Protective factors
Time frame: Two years
Self-reported protective factors measured with the Global School-based Student Health Survey (GSHS)
Sexual behaviors
Time frame: Two years
Self-reported sexual behaviors measured with the Global School-based Student Health Survey (GSHS)
Tobacco use
Time frame: Two years
Self-reported tobacco use measured with the Global School-based Student Health Survey (GSHS)
Violence and unintentional injury
Time frame: Two years
Self-reported violence and unintentional injury measured with the Global School-based Student Health Survey (GSHS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 37407059Guthold 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regina Guthold, PhD principal investigator
World Health Organization
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral interventions targeting multiple risk behaviors as well as protective factors and School-level interventions targeting the school environment and system in people with Healthy, run by World Health Organization at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ghana, India, Jamaica, Morocco, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regina Guthold, PhD (+41 79 621 5691, gutholdr@who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: Two years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.