The Growing Well Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-4
SponsorUniversity of Leeds
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Children aged between 6 months and 5 years living in Leeds, Doncaster and East London.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dietary intake and patterns (including vegetarian, vegan, and dairy-free diets)
BehavioralAssessment 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (2026) and follow-up 12 months later2
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.
Time frame
Follow-up only (2027)Secondary outcomes
1
Dental health
Presence of plaque, sepsis and enamel defects associated with dentinal cavitation.
Time frame
Follow-up only (2027)2
Length/Height-for-Age Z-score
Length or height (cm) relative to age are used for this indicator. Length/height-for-age calculated using UK WHO growth standards and expressed as a Z-score (range -6 to +6). Higher Z-scores indicate greater attained length/height relative to age. Following international standards, if the child is \<2years indicator will use length, and if \>=2 years height.
Time frame
Baseline (2026) and 12-month follow up3
Weight-for-Age Z-score
Weight (kg) in relation to age are used for this indicator. Weight-for-age calculated using UK WHO growth standards and expressed as a Z-score. Values within the range of -6 and +5 Z scores. Higher scores indicate greater body weight relative to age.
Time frame
Baseline (2026) and 12-month follow up4
Body Mass Index for-Age Z-score
Body mass index (BMI) calculated as weight (kg)/height or length (m²), standardized for age using UK WHO growth standards and expressed as a Z-score. Values range between -5 and + 5 Z scores. Higher scores indicate higher BMI relative to age.
Time frame
Baseline (2026) and 12 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leeds
Lead sponsor
National Centre for Social Research, London, UK
Collaborator
Queen Mary University of London
Collaborator
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Barts & The London NHS Trust
Collaborator
Source ClinicalTrials.gov