ClinicalTrials.gg
RecruitingNCT07698158GWSUpdated Jul 13, 2026

The Growing Well Study

An observational study in Dietary Behaviors, Child Growth and Development and Dental Health, sponsored by University of Leeds. Recruiting at 6 sites in United Kingdom. Open to participants aged 6 Months to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of Leeds · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,890
Ages
6 Months to 4 Years
Sex
All
01

Study 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.

Read the detailed description

Research question

The investigators will answer questions posed by the recent Scientific Advisory Committee on Nutrition (SACN) report:

  • What are age-appropriate food and drink portion sizes in relation to growth and dental health?
  • What are the short-term effects (12 months) on growth and dental health of commercial foods for children; vegetarian/vegan/dairy-free dietary patterns?
  • What is the impact on growth and dental health of macro- and micro-nutrient intakes; fruit juices/free sugars; formula milks for 12m+; sweeteners?

Background In the UK, little contemporary data exists on diet in young children but worrying trends in preschool overweight and dental health are reported. Current young child diets do not meet dietary recommendations and evidence-driven age-appropriate portion size recommendations are missing. Further research into the impact of plant-based diets, the use of commercial foods, and toddler milks is also recommended by SACN.

Aims and Objectives To provide new evidence on diet in children aged 6 months - 5 years, linked to optimum growth and dental health. Quantifying age-appropriate portion sizes for different foods and drinks.

  • Collect data on child dietary intake, portion sizes.
  • Collect data on parent and child attributes, including child anthropometrics and dental health.
  • Evaluate food and nutrient intake in relation to i) growth over 12 months, ii) child and parent characteristics, including ethnic diversity, deprivation and iii) dental health.
  • Make recommendations for nutrition and age-appropriate portions.

Methods 1,890 parents of young children (6 months - 4 years) will be recruited through a combination of community outreach and hospital-based recruitment. This will include participants from the Born and Bred in (BaBi) Network birth cohorts in Leeds, Doncaster, and East London, as well as from the Generation Study. Recruitment will include approximately equal distribution in each year bracket, 20% non-white, 20% from deprived locations, and 15% vegetarian/vegan/non-dairy diet. Protocols are in place to ensure recruitment targets are met. Protocols, consent forms, and questionnaires have been co-designed with our Parent Advisory Group.

Baseline data will be collected using i) online survey, ii) fieldworker-measured height/length, weight, abdominal circumference, iii) 3 x 24h measures of diet spanning several months, and may possibly include iv) saliva collection in a subsample (if funding is obtained). Follow-up data collected after 12 months will repeat baseline measures and additionally include a dental assessment.

Cross-sectional and longitudinal analysis will explore how growth and dental health are influenced by nutrient intakes, diet pattern, and food portion sizes. Age/gender appropriate portion sizes for key food groups will be characterised with linear mixed-effects modelling for specific foods/food groups in relation to the child's position on the growth chart centiles.

Anticipated Impact and Dissemination Knowledge of associations between food and nutrient intakes and growth/dental health and of suboptimal intakes in vegan/vegetarian/dairy-free or vulnerable groups will enable evidence-based guidelines on age-appropriate portion sizes and optimal diet composition.

Guideline promotion to key stakeholders and visual feedback to participants will support intake of age-appropriate portions and healthier diets. Ultimately resulting in healthier children, with better dental health. Guidelines will also highlight social inequalities, indicating specific actions to redress imbalances

02

Conditions studied

  • Dietary Behaviors
  • Child Growth and Development
  • Dental Health
  • Dietary Intakes

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Keywords

  • Early Years
  • Children
  • Nutrition
  • Portion Size
  • Commercial Foods
  • Plant-Based Diet
  • Growth
  • Dental Health
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's planned enrollment of 1,890 is above the median of 235 across 341 observational studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,890 participants (estimated)
Patient registry
No

Interventions

  • BehavioralDietary intake and patterns (including vegetarian, vegan, and dairy-free diets)

    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

06

What researchers measure

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 later

  2. 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 up

  3. 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 up

  4. 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-up

  5. Waist circumference

    Waist circumference at the navel level measured using standard anthropometric procedures. Unit of measure are cm, no predetermined minimum or maximum values. Higher values indicate larger waist circumference.

    Time frame: Baseline (2026) and 12 month follow-up

07

Study locations

6 of 6 sites recruiting
08

References and documents

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Where appropriate, de-identified datasets may be shared with external collaborators in response to reasonable, ethically approved data sharing requests. In such cases, formal data sharing agreements will be required.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.

Of 113 non-industry observational studies under Behavior, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 57. This study's planned 20 months is above that.

Counting every sponsor, half of 119 studies reached it within 17 months; a quarter within 6 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2026
First posted
Jul 13, 2026
StartActual
Jan 5, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Oct 2027
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07698158
Collaborators
National Centre for Social Research, London, UK, Queen Mary University of London, Doncaster And Bassetlaw Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust
Responsible party
Diane Threapleton (Senior Research Fellow, University of Leeds) — Principal investigator
First posted
Jul 13, 2026
Start date
Jan 5, 2026
Primary completion
Sep 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Diane Threapleton E Threapleton, PhD
Contact
D.E.Threapleton@leeds.ac.uk
+441133435530
Sofia Barragan Vazquez del Mercado, PhD
Contact
s.barragan@leeds.ac.uk
+441133435530
Janet E Cade, PhD
principal investigator · University of Leeds
Diane E Threapleton, PhD
principal investigator · University of Leeds

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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