NCT07698158

Brief Summary

What are the study aims? To understand more about eating habits and age-appropriate food/drink portion sizes of children aged 6 months-5 years old, and how this affects their growth and dental health. Why is this research important? Healthy diets in early years are important for growth and development. However, clear guidance for parents on what and how much children should eat is missing due to lack of up-to-date information. What will the investigators do? Information will be collected at two time points. At baseline, parents/guardians of children aged 6 months-4 years from Leeds, Doncaster and East London will complete questionnaires about their child's sociodemographic information and food intake. They will be asked to record what their child eats for three separate one-day periods using an online system called 'myfood24'. Parents will also attend one in-person session for measuring their child's length/height, weight, and waist circumference. At follow-up one year later, parents/guardians will complete surveys again, with another in-person session to look at growth and assess dental health. What do the investigators expect to achieve and what happens next? They want to understand how growth and dental health are influenced by nutrient intakes, dietary patterns, and portion sizes for key food groups. They will also identify how much of different foods children should be eating, and whether commercial foods and sweet drinks are relevant. They will explore which dietary factors can support healthier children; and how low intakes of key foods or vitamins/minerals in vulnerable groups could be redressed. The study will provide unique information, allowing for development of recommendations for parents and policy-makers on age-appropriate portions, on achieving good nutrition in UK children and within special dietary groups, and on dietary considerations in caring for children's teeth.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,890

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress33%
Jan 2026Oct 2027

Study Start

First participant enrolled

January 5, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

June 23, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Early YearsChildrenNutritionPortion SizeCommercial FoodsPlant-Based DietGrowthDental Health

Outcome Measures

Primary Outcomes (2)

  • Weight-for-height/length Z scores

    Weight (kg) and length or height (cm) are combined to this indicator. A standardized measure of body weight relative to height or length and sex. Following international reccomendations, length is used for children \<2 years and height for those \>=2 years. Scores typically range from -5 to +5 Z scores, with higher scores indicating greater weight relative to height/length.

    Baseline (2026) and follow-up 12 months later

  • Dental caries

    Prevalence following the National Dental Epidemiology Programme methodology, including a visual-only examination by trained and calibrated dental examiners, using the dentinal cavitation (d₃mft) as diagnostic threshold.

    Follow-up only (2027)

Secondary Outcomes (5)

  • Dental health

    Follow-up only (2027)

  • Length/Height-for-Age Z-score

    Baseline (2026) and 12-month follow up

  • Weight-for-Age Z-score

    Baseline (2026) and 12-month follow up

  • Body Mass Index for-Age Z-score

    Baseline (2026) and 12 month follow-up

  • Waist circumference

    Baseline (2026) and 12 month follow-up

Interventions

Assessment of dietary intake, patterns, and food/drink portion sizes in infants and young children, including consumption of commercial foods, formula milks, fruit juices, and free sugars, and comparison of different dietary patterns (e.g., vegetarian, vegan, dairy-free diets). Dietary data are collected at baseline and at 12-month follow-up.

Also known as: Food and drink portion sizes, Nutrient intake (macro- and micronutrients, free sugars, sweeteners), Commercial foods, Fruit juices

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged between 6 months and 5 years living in Leeds, Doncaster and East London.

You may qualify if:

  • Children aged 6 months-4 years along with their parents or guardians who reside in or near one of the three study locations and planned fieldwork sites: Leeds, Doncaster, or East London. For East London, eligibility includes individuals living in or near Tower Hamlets or an adjacent borough
  • All participants are eligible regardless of background, language, educational ability, or literacy level.

You may not qualify if:

  • Plan to move outside of the study area within the next 12 months
  • Children not living with the consenting parent/guardian for any part of the week or not living with the consenting parent/guardian at the time of data collection (e.g. in care, hospital, or living wholly with another family member).
  • Children with significant oral feeding difficulties (e.g. tube-feeding or developmental delays)
  • Children that have been diagnosed with a long-term condition that affects their growth or development (e.g. hormonal or genetic conditions)
  • Children from subgroups where quotas have been filled will be excluded to maintain balanced representation across all study groups (e.g., age 3, non-deprived locations).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, West Yorkshire, LS6 2EF, United Kingdom

RECRUITING

Community settings across Doncaster

Doncaster, West Yorkshire, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS6 2EF, United Kingdom

RECRUITING

Community settings across Leeds

Leeds, West Yorkshire, United Kingdom

RECRUITING

Barts Health NHS Trust

London, West Yorkshire, LS6 2EF, United Kingdom

RECRUITING

Community settings across East London

London, West Yorkshire, LS6 2EF, United Kingdom

RECRUITING

Related Links

MeSH Terms

Interventions

EatingDiet, VeganFoodMicronutrientsSweetening AgentsFruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDiet, VegetarianDiet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietFood and BeveragesPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsBeverages

Study Officials

  • Janet E Cade, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR
  • Diane E Threapleton, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Threapleton E Threapleton, PhD

CONTACT

Sofia Barragan Vazquez del Mercado, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 13, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations