- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07698158
The Growing Well Study (GWS)
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Diane Threapleton E Threapleton, PhD
- Phone Number: +441133435530
- Email: D.E.Threapleton@leeds.ac.uk
Study Contact Backup
- Name: Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
Study Locations
-
-
West Yorkshire
-
Doncaster, West Yorkshire, United Kingdom, LS6 2EF
- Recruiting
- Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
Doncaster, West Yorkshire, United Kingdom
- Recruiting
- Community settings across Doncaster
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
Leeds, West Yorkshire, United Kingdom, LS6 2EF
- Recruiting
- Leeds Teaching Hospitals NHS Trust
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
Leeds, West Yorkshire, United Kingdom
- Recruiting
- Community settings across Leeds
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
London, West Yorkshire, United Kingdom, LS6 2EF
- Recruiting
- Barts Health NHS Trust
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
London, West Yorkshire, United Kingdom, LS6 2EF
- Recruiting
- Community settings across East London
-
Contact:
- Sofia Barragan Vazquez del Mercado, PhD
- Phone Number: +441133435530
- Email: s.barragan@leeds.ac.uk
-
Contact:
- Chloe L Thackray, BSc
- Phone Number: +441133435530
- Email: C.L.Thackray@leeds.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (2026) and follow-up 12 months later
|
|
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.
|
Follow-up only (2027)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental health
Time Frame: Follow-up only (2027)
|
Presence of plaque, sepsis and enamel defects associated with dentinal cavitation.
|
Follow-up only (2027)
|
|
Length/Height-for-Age Z-score
Time Frame: Baseline (2026) and 12-month follow up
|
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.
|
Baseline (2026) and 12-month follow up
|
|
Weight-for-Age Z-score
Time Frame: Baseline (2026) and 12-month follow up
|
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.
|
Baseline (2026) and 12-month follow up
|
|
Body Mass Index for-Age Z-score
Time Frame: Baseline (2026) and 12 month follow-up
|
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.
|
Baseline (2026) and 12 month follow-up
|
|
Waist circumference
Time Frame: Baseline (2026) and 12 month follow-up
|
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.
|
Baseline (2026) and 12 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Janet E Cade, PhD, University of Leeds
- Principal Investigator: Diane E Threapleton, PhD, University of Leeds
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Therapeutics
- Pharmacologic Actions
- Chemical Actions and Uses
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Nutritional Physiological Phenomena
- Specialty Uses of Chemicals
- Beverages
- Diet, Plant-Based
- Diet Therapy
- Nutrition Therapy
- Diet
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Food Additives
- Food Ingredients
- Flavoring Agents
- Nutrients
- Diet, Vegetarian
- Micronutrients
- Food
- Eating
- Sweetening Agents
- Diet, Vegan
- Fruit and Vegetable Juices
Other Study ID Numbers
- 2025-NCT43
- NIHR207073 (Other Grant/Funding Number: National Institute for Health and Care Research (NIHR))
- 347332 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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