Physical InactivityNCT05839080
FoodACT: Investigating the Impact of a School Garden Intervention on Children's Food Literacy, Climate Literacy, School Motivation and Physical Activity
A study testing Gardens to Bellis in people with Physical Inactivity and Literacy, run by Center for Clinical Research and Prevention at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the efficacy of a schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity. The study will also investigate the contextual characteristics in the garden using systematic observations and the pupil´s experience of the… Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Literacy, Motivation
- What is being tested?
- Gardens to Bellis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 31 Dec 2026
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4th-5th grade school classes in Danish municipal primary and lower secondary schools participating in the 'Gardens to Bellis' intervention.
- Classes not involved in other school development or research projects.
- Participants with parents (or legal guardian) having provided written informed consent.
Who cannot join
- Pupils with significant health problems as judged by the investigators will be excluded from the analysis (Sub-study 1-3).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Research and Prevention
Frederiksberg, Capital Region, 2000
About this study
Official title: FoodACT: Investigating the Impact of a School Garden Intervention on Children's Food Literacy, Climate Literacy, Physical Activity, and School Motivation
The purpose of this study is to investigate the efficacy of a schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity. The study will also investigate the contextual characteristics in the garden using systematic observations and the pupil´s experience of the intervention with focus-groups interviews.
Read the detailed description
Globally, the prevalence of obesity and severe obesity among children and youth is rising. Inactivity and unhealthy diet are often associated with obesity which can lead to detrimental health outcomes such as cardiovascular disease and type-2 diabetes. Schools are considered a key setting for promoting children and adolescents' food literacy, climate literacy, physical activity and to improve their mental and social health. Interventions in schools have a broad impact because all children spent the majority of their waking hours in school independent of their socio-economic- and cultural background. FoodACT aims to invetigate an well-established schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity.
School gardens create an enabling environment for increasing student's food literacy and climate literacy, where an active component is that the pupils cultivate and prepare their own crops through a program that extends through nine months and therefore becomes an integrated part of the pupils schooling. The children's' physical activty is affected without it being the focus of the school garden programs. Pupils get up from the chair in the classroom, use active transportation for example by foot or bike to the school garden and are activated by work such as digging, lifting and watering their own plot. Some school garden interventions also invovle and activate the pupils families, which increases the sustainability of the interventions effects. Previous research has stated that schools are considered a key setting for promoting children and adolescents' food literacy and physical activity and to improve their mental and social health. Relocating teaching to an outdoor nature setting, which is a central ingredients of school garden interventions, has shown to be positively related to increased physical activity in both boys and girls during the school day. Furthermore, contextual and experience related characteristics such as tasks, motions, associations and interactions realted to the school garden has not been captured.
Therefore, the aim of FoodACT is to investigate how a school gardening intervention impact pupils food literacy, climate literacy, school motivation and physical activity with a special focus on children with low socio-economics in a controlled design.
In 2023 a pilot-study will be performed to test and adjust the outcome measures.
- Conditions
- Physical Inactivity, Literacy, Motivation
- Being tested
- Gardens to Bellis, No intervention
- Keywords
- School, Physical activity, Outdoor, School garden, Motivation, Food literacy, Climate literacy, Education, Health Promotion
- Medical subject headings
- Sedentary Behavior, Literacy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardens to BellisBehavioural
Also called FoodACT
In FoodACT the school garden intervention that will be investigated is the well described and well-developed intervention called Gardens to Bellis. It involves pupils from 4th-5th grade and their teachers. The classes attend 8 school garden sessions distributed across two school years. The sessions start each year in March and ends in November. Pupils are divided into smaller groups, who gets a plot of which they are responsible for preparing, weed and harvest. The purpose is that pupils can cook their own food with the greens, fruits and berries they harvest in the garden and finds in the nature. The pupils and their families will hatch and harvest the school gardens between the session days.
No interventionBehavioural
Pupils are not receiving any intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | Experimental | Pupils are exposed to the schoolgarden intervention eight times during two school years Receives: Behavioral: Gardens to Bellis |
| Control Schools | Experimental | Pupils are not exposed to the interventions and will complete questionaries Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (PA)
Physical activity will be measured with Sens Motion accelerometers or with Axivity® AX3 accelerometer as described above. The primary outcomes are pupils' physical activity i.e., sedentary behaviour (SED), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA).
Using Sens motion all acceleration data will be processed and transferred into a secure web server via the smartphone. Based on the sensor's orientation (axes) and acceleration, a predefined algorithm categorises the measurements in predefined behaviour activities, e.g., sitting, lying down, standing, walking, cycling and number of steps. In addition, a categorisation of intensity levels is predefined e.g., moderate, and high physical activity.
Measured: 9 months
Food literacy (FL)
FL will be measured using the Food Literacy Quesionare designed for school children (FLQ-sc; (Stjernqvist, Elsborg, et al., 2021). The questionnaire is developed and validate to school children in 6th and 7th grade (aged 12-14). It's a 37 item questionnaire used to access individual FL which is based on Benn 2014 five FL competencies: "to know, "to do", "to sense", "to care" and "to want".
Measured two times in 2024 where change is being assesed.
Measured: 9 months
Climate Literacy (CL)
CL will be measured based on a Climate Litercy Quesionare (Dewaters et.al. 2011), which will be modified and adapted during the pilot-study targeting the right age-group.
Measured two times in 2024 where change is being assesed.
Measured: 9 months
School motivation (SM)
School motivation (SM) will be measured using the Academic Self-Regulation Questionnaire (called SRQ-A). The SRQ-A is a domain-specific self-report questionnaire developed for measuring the level of autonomy relative to doing different types of schoolwork among pupils in late primary and lower-secondary school.
Measured two times in 2024 where change is being assesed.
Measured: 9 months
Secondary outcomes (2)
Systematic observations with PARAGON
The primary outcomes are the pupil's movements, postures, motions, and experience of the intervention activities. When using systematic observations with PARAGON (The Physical Activity Research and Assessment tool for Garden Observation) pupils' movements and motions will be captured when they attend the gardening intervention activities. The observed movements and motions are categorised into four categories: overall PA-level, garden-related tasks, garden related motions, social associations, and interaction
Measured: 9 months
Focus-group interviews
Semi-structured focus-group interviews will be held after a day with gardening intervention activities with both the involved pupils, teachers, parents (or legal guardian) and gardens facilitators. The thematic content analyses will be open to unforeseen themes that may emerge while also keeping a focus on the different target groups' motivation and experience with the intervention.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2024
- Study completion31 Dec 2026 (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 Physical InactivityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study has two different participant samples. In Sub-Study 1 the participants are pupils from 4th-5th grade from Danish municipal primary and lower secondary schools attending the 'Gardens to Bellis' intervention (intervention group) and pupils from 4th-5th grade from Danish municipal primary and lower secondary schools not attending the 'Gardens to Bellis' intervention. In Sub-Study 2 and Sub-Study 3, the participant sample is a subsample of the intervention sample in SS1. The participants are pupil's 4th-5th grade (n=540) from 30 Danish municipal primary and lower secondary schools.
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- University of Copenhagen, Haver til Maver
- Responsible party
- Principal investigator, Peter Elsborg, Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839080
- Sponsor's protocol ID
- NFF22SH0077522
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant-level data can be made available upon reasonable request to the PI such as e.g. verification of the research results. To comply with the European General Data Protection Regulation, and to accommodate article 10 of the Danish Act on Data Protection anonymised participant-level data will be made available on the Open Science Framework five years after the main publication of this study.
Publications
Stage A, Vermund MC, Bolling M, Otte CR, Oest Mullertz AL, Bentsen P, Nielsen G, Elsborg P. The impact of a school garden program on children's food literacy, climate change literacy, school motivation, and physical activity: A study protocol. PLoS One. 2025 Apr 24;20(4):e0320574. doi: 10.1371/journal.pone.0320574. eCollection 2025.
PubMed 40273231
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoodACT: Investigating the Impact of a School Garden Intervention on Children's Food Literacy, Climate Literacy, Physical Activity, and School Motivation
- ClinicalTrials.gov ID
- NCT05839080
- Acronym / sponsor ID
- NFF22SH0077522
- Conditions
- Physical Inactivity, Literacy, Motivation
- Keywords
- School, Physical activity, Outdoor, School garden, Motivation, Food literacy, Climate literacy, Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- University of Copenhagen, Haver til Maver
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (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.
The purpose of this study is to investigate the efficacy of a schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity. The study will also investigate the contextual characteristics in the garden using systematic observations and the pupil´s experience of the intervention with focus-groups interviews.
Detailed description
Globally, the prevalence of obesity and severe obesity among children and youth is rising. Inactivity and unhealthy diet are often associated with obesity which can lead to detrimental health outcomes such as cardiovascular disease and type-2 diabetes. Schools are considered a key setting for promoting children and adolescents' food literacy, climate literacy, physical activity and to improve their mental and social health. Interventions in schools have a broad impact because all children spent the majority of their waking hours in school independent of their socio-economic- and cultural background. FoodACT aims to invetigate an well-established schoolgarden intervention on pupils food literacy, climate literacy, schoolmotivation and physical activity.
School gardens create an enabling environment for increasing student's food literacy and climate literacy, where an active component is that the pupils cultivate and prepare their own crops through a program that extends through nine months and therefore becomes an integrated part of the pupils schooling. The children's' physical activty is affected without it being the focus of the school garden programs. Pupils get up from the chair in the classroom, use active transportation for example by foot or bike to the school garden and are activated by work such as digging, lifting and watering their own plot. Some school garden interventions also invovle and activate the pupils families, which increases the sustainability of the interventions effects. Previous research has stated that schools are considered a key setting for promoting children and adolescents' food literacy and physical activity and to improve their mental and social health. Relocating teaching to an outdoor nature setting, which is a central ingredients of school garden interventions, has shown to be positively related to increased physical activity in both boys and girls during the school day. Furthermore, contextual and experience related characteristics such as tasks, motions, associations and interactions realted to the school garden has not been captured.
Therefore, the aim of FoodACT is to investigate how a school gardening intervention impact pupils food literacy, climate literacy, school motivation and physical activity with a special focus on children with low socio-economics in a controlled design.
In 2023 a pilot-study will be performed to test and adjust the outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study has two different participant samples. In Sub-Study 1 the participants are pupils from 4th-5th grade from Danish municipal primary and lower secondary schools attending the 'Gardens to Bellis' intervention (intervention group) and pupils from 4th-5th grade from Danish municipal primary and lower secondary schools not attending the 'Gardens to Bellis' intervention. In Sub-Study 2 and Sub-Study 3, the participant sample is a subsample of the intervention sample in SS1. The participants are pupil's 4th-5th grade (n=540) from 30 Danish municipal primary and lower secondary schools.
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Behavioral: Gardens to BellisPupils are exposed to the schoolgarden intervention eight times during two school years |
| Control Schools | Experimental | Behavioral: No interventionPupils are not exposed to the interventions and will complete questionaries |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4th-5th grade school classes in Danish municipal primary and lower secondary schools participating in the 'Gardens to Bellis' intervention.
- Classes not involved in other school development or research projects.
- Participants with parents (or legal guardian) having provided written informed consent.
Key exclusion criteria (1 listed)
- Pupils with significant health problems as judged by the investigators will be excluded from the analysis (Sub-study 1-3).
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 |
|---|---|---|
| Gardens to BellisAlso: FoodACTIn FoodACT the school garden intervention that will be investigated is the well described and well-developed intervention called Gardens to Bellis. It involves pupils from 4th-5th grade and their teachers. The classes attend 8 school garden sessions distributed across two school years. The sessions start each year in March and ends in November. Pupils are divided into smaller groups, who gets a plot of which they are responsible for preparing, weed and harvest. The purpose is that pupils can cook their own food with the greens, fruits and berries they harvest in the garden and finds in the nature. The pupils and their families will hatch and harvest the school gardens between the session days. | Behavioural | Intervention schools |
| No interventionPupils are not receiving any intervention | Behavioural | Control Schools |
Primary outcome
Physical activity (PA)
Time frame: 9 months
Physical activity will be measured with Sens Motion accelerometers or with Axivity® AX3 accelerometer as described above. The primary outcomes are pupils' physical activity i.e., sedentary behaviour (SED), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA). Using Sens motion all acceleration data will be processed and transferred into a secure web server via the smartphone. Based on the sensor's orientation (axes) and acceleration, a predefined algorithm categorises the measurements in predefined behaviour activities, e.g., sitting, lying down, standing, walking, cycling and number of steps. In addition, a categorisation of intensity levels is predefined e.g., moderate, and high physical activity.
Food literacy (FL)
Time frame: 9 months
FL will be measured using the Food Literacy Quesionare designed for school children (FLQ-sc; (Stjernqvist, Elsborg, et al., 2021). The questionnaire is developed and validate to school children in 6th and 7th grade (aged 12-14). It's a 37 item questionnaire used to access individual FL which is based on Benn 2014 five FL competencies: "to know, "to do", "to sense", "to care" and "to want". Measured two times in 2024 where change is being assesed.
Climate Literacy (CL)
Time frame: 9 months
CL will be measured based on a Climate Litercy Quesionare (Dewaters et.al. 2011), which will be modified and adapted during the pilot-study targeting the right age-group. Measured two times in 2024 where change is being assesed.
School motivation (SM)
Time frame: 9 months
School motivation (SM) will be measured using the Academic Self-Regulation Questionnaire (called SRQ-A). The SRQ-A is a domain-specific self-report questionnaire developed for measuring the level of autonomy relative to doing different types of schoolwork among pupils in late primary and lower-secondary school. Measured two times in 2024 where change is being assesed.
2 secondary outcomes
Systematic observations with PARAGON
Time frame: 9 months
Focus-group interviews
Time frame: 9 months
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 15 Jan 2025.
- Derived from this study: PubMed 40273231Stage A, Vermund MC, Bolling M, Otte CR, Oest Mullertz AL, Bentsen P, Nielsen G, Elsborg P. The impact of a school garden program on children's food literacy, climate change literacy, school motivation, and physical activity: A study protocol. PLoS One. 2025 Apr 24;20(4):e0320574. doi: 10.1371/journal.pone.0320574. eCollection 2025.
- FoodACT websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised participant-level data can be made available upon reasonable request to the PI such as e.g. verification of the research results. To comply with the European General Data Protection Regulation, and to accommodate article 10 of the Danish Act on Data Protection anonymised participant-level data will be made available on the Open Science Framework five years after the main publication of this study.
Related trials for Physical Inactivity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardens to Bellis in people with Physical Inactivity and Literacy, run by Center for Clinical Research and Prevention at 1 site in Denmark.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (PA) (time frame: 9 months). The study lists 4 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 NCT05839080, 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 15 Jan 2025.