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The Growing Well Study (GWS)

2026년 7월 6일 업데이트: Diane Threapleton, University of Leeds

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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

연구 유형

관찰

등록 (추정된)

1890

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Sofia Barragan Vazquez del Mercado, PhD
  • 전화번호: +441133435530
  • 이메일: s.barragan@leeds.ac.uk

연구 장소

  • 영국
    • West Yorkshire
      • Doncaster, West Yorkshire, 영국, LS6 2EF
        • 모병
        • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
        • 연락하다:
        • 연락하다:
      • Doncaster, West Yorkshire, 영국
        • 모병
        • Community settings across Doncaster
        • 연락하다:
        • 연락하다:
      • Leeds, West Yorkshire, 영국, LS6 2EF
        • 모병
        • Leeds Teaching Hospitals NHS Trust
        • 연락하다:
        • 연락하다:
      • Leeds, West Yorkshire, 영국
        • 모병
        • Community settings across Leeds
        • 연락하다:
        • 연락하다:
      • London, West Yorkshire, 영국, LS6 2EF
        • 모병
        • Barts Health Nhs Trust
        • 연락하다:
        • 연락하다:
      • London, West Yorkshire, 영국, LS6 2EF
        • 모병
        • Community settings across East London
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Weight-for-height/length Z scores
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Dental health
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Leeds

협력자

The Leeds Teaching Hospitals NHS Trust
Barts & The London NHS Trust
Queen Mary University of London
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
National Centre for Social Research, London, UK

수사관

  • 수석 연구원: Janet E Cade, PhD, University of Leeds
  • 수석 연구원: Diane E Threapleton, PhD, University of Leeds

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 5일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 10월 1일

연구 등록 날짜

최초 제출

2026년 6월 23일

QC 기준을 충족하는 최초 제출

2026년 7월 6일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 6일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-NCT43
  • NIHR207073 (기타 보조금/기금 번호: National Institute for Health and Care Research (NIHR))
  • 347332 (기타 식별자: IRAS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

치아 건강에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Ethiopia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다