NCT04277312

Brief Summary

Project Daire is a randomised-controlled factorial design trial working in partnership with primary schools and local food producers evaluating two interventions designed to improve primary school children's knowledge of and interest in food and where it comes from, with the ultimate aim of driving improvement in health, well-being and educational status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 11, 2020

Last Update Submit

February 17, 2020

Conditions

Keywords

Primary School ChildrenFood EducationFood KnowledgeChildhood HealthChildhood Wellbeing

Outcome Measures

Primary Outcomes (2)

  • Change in KIDSCREEN-10 score at 6 months

    Validated well-being questionnaire for children. Completed by KS1 and KS2 pupils.This is an 11-item instrument answered on a 5-point scale and results in one global HRQoL score. Most of the items are formulated positively and in concordance with the scoring, which means a higher score reflects a higher HRQoL. However, some items are formulated negatively and as a consequence the scoring has to be recoded. The scoring method results in T-values with scale means around 50 and standard deviations around 10 with higher values indicating higher HRQoL.

    Baseline (Month 0), 6 months

  • Change in Strengths and Difficulties Questionnaire score at 6 months

    Validated brief behavioural screening questionnaire. Completed by teachers. This 25-item instrument incorporates 5 scales of 5 items, with each item answered on a 3 point scale. All scales represent a negative trait, with the exception of the ProSocial Scale which indicates a positive trait. For each of the 5 scales the score can range from 0 to 10 if all items were completed. A Total Difficulties score is the final score and indicates poorer behaviour. Therefore the lower the score, the better the outcome in terms of behaviour.

    Baseline (Month 0), 6 months

Secondary Outcomes (15)

  • 24 Hour Dietary Record

    Baseline (Month 0), 6 months

  • Food Frequency Questionnaire

    Baseline (Month 0), 6 months

  • Food Shopping, Preparation & Consumption

    Baseline (Month 0), 6 months

  • Perceived cooking competence

    Baseline (Month 0), 6 months

  • Agri-Food Knowledge

    Baseline (Month 0), 6 months

  • +10 more secondary outcomes

Study Arms (4)

Engage

EXPERIMENTAL

The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists.

Behavioral: Engage

Nourish

EXPERIMENTAL

The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities.

Behavioral: Nourish

Nourish and Engage

EXPERIMENTAL

This arm of the intervention delivered both the Nourish and Engage interventions as detailed above.

Behavioral: EngageBehavioral: Nourish

Delayed

NO INTERVENTION

The delayed arm of the intervention was the control arm. Schools randomised to this arm of the study were offered the Engage intervention resources after endpoint data collection.

Interventions

EngageBEHAVIORAL

The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists.

EngageNourish and Engage
NourishBEHAVIORAL

The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities.

NourishNourish and Engage

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mainstream primary schools willing to be randomly assigned to an intervention,
  • Mainstream primary schools willing to engage with the intervention and implement it with their pupils,
  • Mainstream primary schools willing to facilitate pre and post-test data collection in their setting,
  • Mainstream primary schools within the North West region of Northern Ireland.
  • Pupils in Primary 3 (Key Stage 1) and Primary 7 (Key Stage 2) of participating schools were eligible to take part.

You may not qualify if:

  • Secondary schools
  • Non-mainstream schools
  • Schools not in the North West region of Northern Ireland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Related Publications (2)

  • Anderson N, Brennan SF, Lavelle F, Moore SE, Olgacher D, Junkin A, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Elliott CT, McCarthy D, Woodside JV. Process evaluation of Project Daire: a food environment intervention that impacted food knowledge, wellbeing and dietary habits of primary school children. BMC Public Health. 2025 Feb 6;25(1):486. doi: 10.1186/s12889-025-21628-4.

  • Brennan SF, Lavelle F, Moore SE, Dean M, McKinley MC, McCole P, Hunter RF, Dunne L, O'Connell NE, Cardwell CR, Elliott CT, McCarthy D, Woodside JV. Food environment intervention improves food knowledge, wellbeing and dietary habits in primary school children: Project Daire, a randomised-controlled, factorial design cluster trial. Int J Behav Nutr Phys Act. 2021 Feb 4;18(1):23. doi: 10.1186/s12966-021-01086-y.

MeSH Terms

Conditions

Behavior

Interventions

engage 8200

Study Officials

  • Jayne Woodside, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not possible due to the nature of the interventions.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Project Daire is a randomised-controlled, factorial design trial evaluating two interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 20, 2020

Study Start

January 7, 2019

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations