Condition category
Not Applicable
Date applied
06/05/2019
Date assigned
09/05/2019
Last edited
09/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A community-based approach can be a promising strategy for implementing school-based health promotion aimed at stimulating healthy physical activity and dietary behavior. Such an approach builds on the community capacity of multiple stakeholders, empowering them to design and implement tailored activities, supported by the whole school community. The FLASH intervention includes four strategies for building community capacity of students, school personnel and parents:
1) identifying leaders in each stakeholder group
2) stimulating a school culture of participation
3) having stakeholders design and implement tailored activities
4) creating a network of local partners for structural embedding.
The objective of the study is to monitor capacity-building processes of the FLASH intervention and to explore if these processes contribute to changes in community capacity. In addition, we will explore if the FLASH intervention is related to changes in PA, dietary behaviors and BMI of students.

Who can participate?
Students at schools offering prevocational education (lowest education level in the Netherlands) can take part in this study.

What does the study involve?
1) Semi-structured interviews are carried out with different stakeholders (school personnel and parents).
2) Based on photo-elicitation methodology, students are enabled to show what engages, supports and challenges them with regard to choices they make in the healthy school community regarding dietary and physical activity behavior.
3) Students are asked to fill in a questionnaire and their length, weight and waist circumference are measured.

What are the possible benefits and risks of participating?
Possible benefits include a healthier school community, with a healthier school environment. In addition, benefits could also be positive changes in physical activity and dietary behaviors for students. There are no risks of participating in the study.

Where is the study run from?
Vrije Universiteit Amsterdam department of Health Sciences, the Netherlands

When is the study starting and how long is it expected to run for?
September 2016 to February 2019

Who is funding the study?
The Netherlands Organisation for Health Research and Development (ZonMw)

Who is the main contact?
Ms Bonnie van Dongen,
b.m.van.dongen@vu.nl

Trial website

http://www.project-flash.nl/

Contact information

Type

Scientific

Primary contact

Ms Bonnie van Dongen

ORCID ID

Contact details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
+31205983718
b.m.van.dongen@vu.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

50-53105-98-033

Study information

Scientific title

Creating healthy school communities by sound teamwork

Acronym

FLASH

Study hypothesis

It is hypothesized that on the short term, the FLASH intervention will lead to changes in student attitudes towards physical activity (PA) and dietary behavior. On the intermediate term, this will lead to changes in PA and dietary behaviors and on the long-term to changes in BMI and waist-circumference.

Ethics approval

Approved 20/09/2016, Medical Ethics Committee of the VU Medical Centre (Postbus 7057, 1007 MB Amsterdam, The Netherlands; +31 20 444 4444; metc@vumc.nl), ref: 2016.352

Study design

Evaluation study quasi-experimental design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Healthy lifestyles

Intervention

Mapping the situation - needs-assessment:
The FLASH intervention starts with a needs-assessment among a) students and b) key-stakeholders. For students, the needs-assessment is based on photo-elicitation methodology where students are enabled to show what engages, supports and challenges them with regard to choices they make in the healthy school community regarding dietary and PA behavior. Key stakeholders among school personnel and parents are interviewed to identify conditions and strengths in the school community and opportunities for capacity-building within their specific context.

Facilitating community-capacity building:
Several inputs are provided to each school community to facilitate four capacity-building strategies.
- Identifying and appointing leaders: a healthy school coordinator is appointed and is allocated time to create a network of motivated initiators. These coordinators are coached and guided by experts from local organizations
- Creating a school culture of participation: the healthy school coordinator is seen as a starting point. Coaching from experts is focused on small steps and experiences of success. The schools are provide with methods suitable for participation based on evidence.
- Designing and implementing activities: conducting and analyzing the needs-assessment to serve as input. The coordinator will organize a design-thinking session with representatives of all stakeholders to create ideas and solutions. An implementation budget is provided as a start-up recourse
- Creating a network of local support: coaching and guidance are provided by experts from local organizations in different areas (education and public health).
- Coaching from these experts is aimed towards building potential collaboration using their local network based on the needs of the community.

The intervention follows an action-oriented approach where we monitor processes of community-capacity building, the implementation of activities and the influence of contextual factors on these processes in real-life settings. Observed results are used to achieve continuous improvement of processes within capacity-building strategies.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Changes in community-capacity evaluated with the community readiness to change interview method, which includes an anchoring scoring system that can create a score for each community on their level of community-capacity. Interviews take place at the end of school year 2017/18 (June 2018) and at one-year follow-up, June 2019.
2. Changes in health-promotion activities evaluated per intervention school on how they fit within the pillars of the Dutch Healthy-School approach: education, policy, environment and monitoring. A questionnaire is filled out by the healthy school-coordinator at baseline and three-year follow-up.
3. Daily processes related to capacity-building monitored with journals of the healthy school coordinator, with document analysis of meetings held throughout the intervention and with interviews with key stakeholders from local organizations (such as local public health organization, educational organization, municipality). Measurements take place every 26 weeks during the intervention.

Secondary outcome measures

1. PA and dietary behaviors including attitude toward PA and dietary behavior, are measured with a self-reported questionnaire.
2. BMI and waist circumference. Height and weight are measured to calculate BMI. Height, weight, and waist circumference are all measured using a protocol by trained research assistants.

Data are gathered in three cohorts between October and December on a yearly basis starting in 2016. Participants are followed-up on until they leave school or when the study will be concluded (January 2019). Students start in the study when they are in the second grade. In prevocational education, students are intended to leave school after the fourth grade. This leads to the following measurements per cohort:
- Cohort 1 is measured at three time points: in school year 2016/17 (measurement 1), school year 2017/18 (measurement 2) and school year 2018/19 (measurement 3).
- Cohort 2 is measured at three time points: in school year 2017/18 (measurement 1), school year 2018/19 (measurement 2) and school year 2019/20 (measurement 3).
- Cohort 3 is measured at two time points: in school year 2018/19 (measurement 1) and school year 2019/20 (measurement 2).

Overall trial start date

01/04/2016

Overall trial end date

31/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All schools:
1. School offers prevocational education (lowest education level in the Netherlands)
2. School is committed to participate in evaluation research for four years

Inclusion criteria for intervention schools:
1. Willing to implement the FLASH intervention, e.g. create a healthy school community regarding health PA and dietary behavior
2. Willing to facilitate new health-promotion activities
3. Willing to appoint a staff member to coordinate the intervention

Inclusion criteria for control schools:
1. Control schools match on the following characteristics to an intervention school: size (total number of prevocational students registered), physical environment (rural vs. urban environment), types of education offered (school offers exclusively prevocational education vs. schools offer prevocational education and higher types of secondary education)

Individual level:
1. All students enrolled in prevocational education
2. Informed consent from student and parent

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

8 schools and 400 students

Participant exclusion criteria

For control schools:
1. Schools that fall under the direction of the educational organization that co-developed the FLASH intervention. This organization facilitates secondary and vocational education in the North-eastern region of the Netherlands. Therefore, schools in this region are excluded for control schools to prevent contamination of results due to connection between these schools and the educational organization.

Recruitment start date

01/09/2016

Recruitment end date

01/02/2019

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije Universiteit Amsterdam department of Health Sciences
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije Universiteit Amsterdam

Sponsor details

De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
+31205989898
best.secr.few@vu.nl

Sponsor type

University/education

Website

https://science.vu.nl/en/research/health-sciences/index.aspx

Funders

Funder type

Research organisation

Funder name

ZonMw

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/05/2019: Trial’s existence confirmed by Medical Ethics Committee of the VU Medical Centre.