Dietary BehaviorsGWSNCT07698158
The Growing Well Study
An observational study of Dietary Behaviors and Child Growth and Development, run by University of Leeds at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behaviors, Child Growth and Development, Dental Health
- What is being tested?
- Dietary intake and patterns (including vegetarian, vegan, and dairy-free diets)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,890 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 5 Jan 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged between 6 months and 5 years living in Leeds, Doncaster and East London.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, West Yorkshire, LS6 2EF
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
- Recruiting
Community settings across Doncaster
Doncaster, West Yorkshire
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS6 2EF
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
- Recruiting
Community settings across Leeds
Leeds, West Yorkshire
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
- Recruiting
Barts Health NHS Trust
London, West Yorkshire, LS6 2EF
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
- Recruiting
Community settings across East London
London, West Yorkshire, LS6 2EF
Sofia Barragan Vazquez del Mercado, PhD, +441133435530, s.barragan@leeds.ac.uk
Chloe L Thackray, BSc, +441133435530, C.L.Thackray@leeds.ac.uk
About this study
Official title: Growing Well Study: The Role of Portion Size, Plant-based and Commercial Foods on Young Child Growth
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.
Read more
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
- Being tested
- Dietary intake and patterns (including vegetarian, vegan, and dairy-free diets)
- Keywords
- Early Years, Children, Nutrition, Portion Size, Commercial Foods, Plant-Based Diet, Growth, Dental Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intake and patterns (including vegetarian, vegan, and dairy-free diets)Behavioural
Also called Food and drink portion sizes, Nutrient intake (macro- and micronutrients, free sugars, sweeteners), Commercial foods, Fruit juices
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Follow-up only (2027)
Secondary outcomes (5)
Dental health
Presence of plaque, sepsis and enamel defects associated with dentinal cavitation.
Measured: Follow-up only (2027)
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.
Measured: Baseline (2026) and 12-month follow up
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.
Measured: Baseline (2026) and 12-month follow up
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.
Measured: Baseline (2026) and 12 month follow-up
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.
Measured: Baseline (2026) and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start5 Jan 2026
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Diane Threapleton, University of Leeds
- Investigators
- Janet E Cade, PhD, Principal investigator, University of LeedsDiane E Threapleton, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698158
- Sponsor's protocol ID
- 2025-NCT43
- Other IDs
- NIHR207073, 347332
- Acronym
- GWS
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Well Study: The Role of Portion Size, Plant-based and Commercial Foods on Young Child Growth
- ClinicalTrials.gov ID
- NCT07698158
- Acronym / sponsor ID
- GWS / 2025-NCT43
- Keywords
- Early Years, Children, Nutrition, Portion Size, Commercial Foods, Plant-Based Diet, Growth, Dental Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,890 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- 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
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged between 6 months and 5 years living in Leeds, Doncaster and East London.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intake and patterns (including vegetarian, vegan, and dairy-free diets)Also: Food and drink portion sizes, Nutrient intake (macro- and micronutrients, free sugars, sweeteners), Commercial foods, Fruit juicesAssessment 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. | Behavioural | – |
Primary outcome
Weight-for-height/length Z scores
Time frame: Baseline (2026) and follow-up 12 months later
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.
Dental caries
Time frame: Follow-up only (2027)
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.
5 secondary outcomes
Dental health
Time frame: Follow-up only (2027)
Length/Height-for-Age Z-score
Time frame: Baseline (2026) and 12-month follow up
Weight-for-Age Z-score
Time frame: Baseline (2026) and 12-month follow up
Body Mass Index for-Age Z-score
Time frame: Baseline (2026) and 12 month follow-up
Waist circumference
Time frame: Baseline (2026) and 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janet E Cade, PhD principal investigator
University of Leeds
Diane E Threapleton, PhD principal investigator
University of Leeds
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Behaviors and Child Growth and Development, run by University of Leeds at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Threapleton E Threapleton, PhD (+441133435530, D.E.Threapleton@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-height/length Z scores (time frame: Baseline (2026) and follow-up 12 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.