HealthyNCT05249946
FoodStep - a Sustainable Model for Food Services and Early Childhood Education and Care
A study testing FoodStep - a sustainable health-promoting model for food services and early childhood education and care in people with Healthy, run by Suvi Virtanen at 1 site in Finland.
Trial summary
Transformation towards a more climate-friendly and healthy sustainable diet will require major changes in the food system: increase in consumption of plant-based foods and only moderate consumption of animal-based foods. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FoodStep - a sustainable health-promoting model for food services and early childhood education and care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFinland
- Study dates
- 29 Nov 2021to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Are attending a full time daycare
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Transformation towards a more climate-friendly and healthy sustainable diet will require major changes in the food system: increase in consumption of plant-based foods and only moderate consumption of animal-based foods. In the FoodStep -project, the investigators will develop a sustainable model for food system that reduces the climate impacts of the food system in early childhood education and care. The impact of the changes on children's nutrition, the climate impact of the diet, and the cost of food services will be assessed in a randomised controlled trial. In addition, the effects of the model on the knowledge and attitudes of decision-makers, experts in food service and early childhood education, and families are studied. Based on the project, the model can be applied nationally as part of Finland's climate change mitigation and adaptation strategy. Study aim to a sustainable food system reform through concrete guidelines, communication, and action initiatives.
- Conditions
- Healthy
- Being tested
- FoodStep - a sustainable health-promoting model for food services and early childhood education and care
- Keywords
- Nutrition, Health, Food System, Sustainability, Children, Microbiome, Health Economics, Climate neutrality, Early childhood education, Food catering, Cost-effectiveness analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodStep - a sustainable health-promoting model for food services and early childhood education and careOther
The investigators create a sustainable food system model that reduces the climate impact of the food system in early childhood education and care. In practice, the investigators i) promote plant-rich recipes, sustainable food purchases and consumption through municipality food services, ii) renew food education, and iii) reduce food waste in early education and care. To ensure the feasibility and long-term commitment, the investigators bring together municipal stakeholders and key actors within the food system and education sectors to co-create the content of a sustainable food system intervention. The randomized controlled intervention will be carried out at 26 daycare centers within four municipalities in Finland. The impact of the changes at a food system level on children's dietary intake and nutritional status, costs of the whole food system, the climate impact of the menus and children's diets as well as food waste in the daycare centers will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | * increasing provision of vegetables and sustainable fish in food offered in early childhood education and care (ECEC) and adjusting intake of meat and milk to reasonable levels to meet recommendations
* advancing food education, reducing food waste and assessing the climate and financial impacts of the shift towards a more plant-based diet Receives: Other: FoodStep - a sustainable health-promoting model for food services and early childhood education and care |
| Control group | No intervention | Food supply and food education continue as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daycare diet of the children
The investigators assess the change in vegetable, red meat and milk supply at daycare measured with Food Frequency Questionnaire.
Measured: Before the intervention and 1 year after the intervention
Change in climate impact of Food System model at systemic level
The investigators assess the change in carbon footprint of daycare food supply.
Measured: Before the intervention and 1 year after the intervention
Change in food service cost of Food System model at systemic level
The investigators assess how the costs change at food services due to the food system intervention and how cost-effective is the food system intervention compared to the food system as usual.
Data comes from accounting of food services and book keeping: time spent to different tasks in food services.
Measured: Before the intervention and 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start29 Nov 2021
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Cluster-randomized Trial
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suvi Virtanen
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, Natural Resources Institute Finland, Laurea University of Applied Sciences
- Responsible party
- Sponsor-investigator, Suvi Virtanen, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249946
- Sponsor's protocol ID
- THL/1646/6.00.00/2021
- Status last verified
- Sep 2023
- First submitted
- 29 Nov 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Itkonen ST, Meinila J, Niinisto S, Raulio S, Vepsalainen H, Korkalo L, Kinnunen S, Akerlund M, Korhonen TE, Vihervaara T, Forma L, Saarinen M, Virtanen SM, Erkkola M. A 10-month cluster-randomized trial to shift towards plant-forward meals in early childhood education and care centres: effects on bone and mineral metabolism in Finnish children. Eur J Nutr. 2026 Jul 23;65(5):219. doi: 10.1007/s00394-026-04063-y.
PubMed 42489936Akerlund M, Kytta V, Meinila J, Pietila A, Korhonen TE, Vepsalainen H, Korkalo L, Kinnunen S, Niinisto S, Raulio S, Forma L, Erkkola M, Saarinen M, Virtanen SM. The effect of system-level intervention in early childhood education and care on children's dietary intake and environmental impact of the diet. Eur J Nutr. 2026 Jul 17;65(5):216. doi: 10.1007/s00394-026-04064-x.
PubMed 42469529Vepsalainen H, Kinnunen S, Niinisto S, Forma L, Itkonen ST, Korhonen TE, Korkalo L, Kuusipalo H, Meinila J, Nissinen K, Raulio S, Sambell R, Akerlund M, Virtanen SM, Erkkola M. Implementation and effectiveness of a food education intervention to promote plant-based foods: a partially cluster-randomized controlled trial. Int J Behav Nutr Phys Act. 2026 Apr 22;23(1):59. doi: 10.1186/s12966-026-01924-x.
PubMed 42021333
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoodStep - a Sustainable Model for Food Services and Early Childhood Education and Care
- ClinicalTrials.gov ID
- NCT05249946
- Acronym / sponsor ID
- THL/1646/6.00.00/2021
- Conditions
- Healthy
- Keywords
- Nutrition, Health, Food System, Sustainability, Children, Microbiome, Health Economics, Climate neutrality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Suvi VirtanenOther government
- Collaborators
- University of Helsinki, Natural Resources Institute Finland, Laurea University of Applied Sciences
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 22 Feb 2022 (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.
Transformation towards a more climate-friendly and healthy sustainable diet will require major changes in the food system: increase in consumption of plant-based foods and only moderate consumption of animal-based foods. In the FoodStep -project, the investigators will develop a sustainable model for food system that reduces the climate impacts of the food system in early childhood education and care. The impact of the changes on children's nutrition, the climate impact of the diet, and the cost of food services will be assessed in a randomised controlled trial. In addition, the effects of the model on the knowledge and attitudes of decision-makers, experts in food service and early childhood education, and families are studied. Based on the project, the model can be applied nationally as part of Finland's climate change mitigation and adaptation strategy. Study aim to a sustainable food system reform through concrete guidelines, communication, and action initiatives.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: FoodStep - a sustainable health-promoting model for food services and early childhood education and care* increasing provision of vegetables and sustainable fish in food offered in early childhood education and care (ECEC) and adjusting intake of meat and milk to reasonable levels to meet recommendations * advancing food education, reducing food waste and assessing the climate and financial impacts of the shift towards a more plant-based diet |
| Control group | No intervention | –Food supply and food education continue as usual. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Are attending a full time daycare
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| FoodStep - a sustainable health-promoting model for food services and early childhood education and careThe investigators create a sustainable food system model that reduces the climate impact of the food system in early childhood education and care. In practice, the investigators i) promote plant-rich recipes, sustainable food purchases and consumption through municipality food services, ii) renew food education, and iii) reduce food waste in early education and care. To ensure the feasibility and long-term commitment, the investigators bring together municipal stakeholders and key actors within the food system and education sectors to co-create the content of a sustainable food system intervention. The randomized controlled intervention will be carried out at 26 daycare centers within four municipalities in Finland. The impact of the changes at a food system level on children's dietary intake and nutritional status, costs of the whole food system, the climate impact of the menus and children's diets as well as food waste in the daycare centers will be examined. | Other | Intervention group |
Primary outcome
Change in daycare diet of the children
Time frame: Before the intervention and 1 year after the intervention
The investigators assess the change in vegetable, red meat and milk supply at daycare measured with Food Frequency Questionnaire.
Change in climate impact of Food System model at systemic level
Time frame: Before the intervention and 1 year after the intervention
The investigators assess the change in carbon footprint of daycare food supply.
Change in food service cost of Food System model at systemic level
Time frame: Before the intervention and 1 year after the intervention
The investigators assess how the costs change at food services due to the food system intervention and how cost-effective is the food system intervention compared to the food system as usual. Data comes from accounting of food services and book keeping: time spent to different tasks in food services.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 42489936Itkonen ST, Meinila J, Niinisto S, Raulio S, Vepsalainen H, Korkalo L, Kinnunen S, Akerlund M, Korhonen TE, Vihervaara T, Forma L, Saarinen M, Virtanen SM, Erkkola M. A 10-month cluster-randomized trial to shift towards plant-forward meals in early childhood education and care centres: effects on bone and mineral metabolism in Finnish children. Eur J Nutr. 2026 Jul 23;65(5):219. doi: 10.1007/s00394-026-04063-y.
- Derived from this study: PubMed 42469529Akerlund M, Kytta V, Meinila J, Pietila A, Korhonen TE, Vepsalainen H, Korkalo L, Kinnunen S, Niinisto S, Raulio S, Forma L, Erkkola M, Saarinen M, Virtanen SM. The effect of system-level intervention in early childhood education and care on children's dietary intake and environmental impact of the diet. Eur J Nutr. 2026 Jul 17;65(5):216. doi: 10.1007/s00394-026-04064-x.
- Derived from this study: PubMed 42021333Vepsalainen H, Kinnunen S, Niinisto S, Forma L, Itkonen ST, Korhonen TE, Korkalo L, Kuusipalo H, Meinila J, Nissinen K, Raulio S, Sambell R, Akerlund M, Virtanen SM, Erkkola M. Implementation and effectiveness of a food education intervention to promote plant-based foods: a partially cluster-randomized controlled trial. Int J Behav Nutr Phys Act. 2026 Apr 22;23(1):59. doi: 10.1186/s12966-026-01924-x.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 FoodStep - a sustainable health-promoting model for food services and early childhood education and care in people with Healthy, run by Suvi Virtanen at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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 Finland. 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?
Results are not available in the source record.
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?
Change in daycare diet of the children (time frame: Before the intervention and 1 year after the intervention). The study lists 3 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 NCT05249946, which also lists 3 linked publications.
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 Sep 2023.