NCT07055126

Brief Summary

This randomised controlled dietary intervention study aims to test the effect of introducing fresh meat and vegetable-based recipes and targeted dietary resources into a healthy, sustainable toddler diet on dietary intakes relative to a control group consuming a standard diet based on Irish healthy eating guidelines. This study aims to recruit 80 young children (24-42 months old) who will be randomised to an intervention (provided with individualised dietary counselling, alongside a targeted healthy eating resource, focused on incorporating fresh red meat and vegetable based recipes into a sustainable and safe diet for young children), or control group receiving (provided with basic healthy eating advice as per the Food Safety Authority of Ireland's Food-Based Dietary Guidelines for 1-5-year-olds). Participants will:

  • Include any of the recipes in their child's diet on 3 occasions during the week, for 12 weeks
  • Complete a variety of validated nutrition and feeding questionnaires
  • Complete 2 onsite visits, at the baseline and endpoint of the intervention period The provision of targeted dietary counselling with nutritional resources and techniques will allow us to investigate the impact of these strategies on improving the overall diet of young children.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

May 29, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

May 29, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

young childrennutrition educationdietary assessmentnutritional resources

Outcome Measures

Primary Outcomes (1)

  • Change in dietary intake of key nutrients (iron, zinc, vitamin A, vitamin B12, protein and total energy) from baseline to 12 weeks

    Assessment of change in dietary intake of iron, zinc, vitamin A, vitamin B12, protein, and total energy from baseline to week 12 in toddlers (aged 24-42 months), as measured by a 2-day weighed food and drink diary analyzed using Nutritics software.

    From baseline to 12 weeks

Secondary Outcomes (22)

  • Change in weight (kilograms) from baseline to 12 weeks

    From baseline to 12 weeks

  • Change in height (meters) from baseline to 12 weeks

    From baseline to 12 weeks

  • Parent reported feasibility and acceptability of the healthy eating resource and recipes

    Week 12 (Endpoint Visit)

  • Change in mean parental food neophobia score as measured by the Food Neophobia Scale from baseline to 12 weeks

    From baseline to 12 weeks

  • Change in mean score on the Cooking Skills Questionnaire (CSQ) from baseline to 12 weeks

    From baseline to 12 weeks

  • +17 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Parents/guardians of study participants will be provided with basic healthy eating advice, as per the Food Safety Authority of Ireland's Food-Based Dietary Guidelines for 1-5-year-olds (Food Safety Authority of Ireland, 2020).

Intervention Group

EXPERIMENTAL

Parents/guardians of study participants will be given individualised dietary counselling, coaching and resource provision around healthy eating, with a particular focus on incorporating fresh meat and vegetables into a healthy, sustainable and safe diet for young children.

Other: Individualised dietary counselling, coaching and resource provision around healthy eating for young children

Interventions

Study participants randomised to receive the intervention will receive nutrition education support, through individualised dietary counselling, coaching and resource provision around healthy eating, with a particular focus on incorporating fresh meat and vegetables into a healthy, sustainable and safe diet for young children. Those in the control group will not receive this individualised nutrition education and supports.

Intervention Group

Eligibility Criteria

Age24 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child aged between 24-42 months (at time of study recruitment).
  • In general good health.
  • Following an unrestricted diet.
  • Capable of completing the study assessments.
  • Parent/guardian must be willing to provide written informed consent for their child's participation.

You may not qualify if:

  • \- Follows a vegetarian or vegan or meat-avoidant diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Human Nutrition Studies Unit

Cork, Cork, T12 K8AF, Ireland

Location

Human Nutrition Studies Unit, School of Food and Nutritional Sciences, University College Cork.

Cork, Ireland, Ireland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2025

First Posted

July 8, 2025

Study Start

June 6, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations