NCT05249946

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

November 29, 2021

Last Update Submit

September 14, 2023

Conditions

Keywords

NutritionHealthFood SystemSustainabilityChildrenMicrobiomeHealth EconomicsClimate neutralityEarly childhood educationFood cateringCost-effectiveness analysis

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Before the intervention and 1 year after the intervention

Study Arms (2)

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

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Are attending a full time daycare

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Finnish Institute for Health and Welfare

Helsinki, FI-00271, Finland

Location

MeSH Terms

Interventions

Food Services

Intervention Hierarchy (Ancestors)

Food IndustryIndustryTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster-randomized Trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

November 29, 2021

First Posted

February 22, 2022

Study Start

November 29, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations