Child Growth and Development in East London (CGDEL)

May 15, 2025 updated by: Queen Mary University of London
The overarching objective of this research is to detect poor growth and delayed development early in childhood by developing an automated growth-screening algorithm. The screening algorithm will be created using cohort data and piloted for feasibility and acceptability in Tower Hamlets. The ultimate goals are to detect linear growth failure and delayed development early to identify two groups of children: first, children with serious underlying medical disorders, in whom earlier diagnosis and management would improve clinical outcomes; and second, children whose poor growth and/or delayed development is a manifestation of socioeconomic disadvantage, in whom targeted pre-school interventions may improve long term health and education outcomes.

Study Overview

Detailed Description

Aim 1, Pilot an automated growth screening algorithm in Tower Hamlets

600 pre-school children at age 2-2.5 years will be enrolled into a pilot screening programme, following written informed parental consent. Children will be identified when they have their 2-2.5 year contact as part of the Healthy Child Programme. As per standard care, measures will be taken of the child's height using a stadiometer and weight using digital weighing scales. In addition to these measurements will be the child's head circumference, their height using a phone App and a record taken of previous anthropometric data including birthweight from the Personal Health Record. Parents' heights will also be recorded where possible. Next, families will be offered an additional height measurement at 3-3.5 years in the community, which is not currently part of standard care. Child height will then be recorded as part of the routine National Child Measurement Programme at 4-5 years of age, and linked to primary care data, enabling the growth-screening algorithm to be applied to these three data-points (2-2.5 years, 3-3.5 years and 4-5 years). At each height measurement the study team will identify the 2% of children with the poorest growth, in whom prior studies show a high prevalence (30-40%) of medical disorders and contact parents to offer referral to the paediatric endocrinology clinic at the Royal London Hospital. The study team will evaluate acceptability and feasibility of the screening and referral process, using parental and healthcare professional questionnaires. There will be an evaluation of the uptake by calculating the proportions screened, referred, investigated in clinic and diagnosed with medical disorders.

Focus group discussions will also be held with caregivers (one in English language and one in Sylheti) and with Health Visitors, to get an idea of how they feel about screening and identify potential barriers to a larger scale roll out.

Aim 2, Generate pilot data to investigate the best indicators to detect poor school readiness and/or developmental problems in early childhood.

As part of routine care, each child's development will be assessed using both the caregiver and professional components of the The Ages & Stages Questionnaire (ASQ-3). Following the 2-2.5 year contact, a subset of children (n = 150) will be invited to attend a separate appointment in the community to have a more detailed developmental assessment to measure gross motor, fine motor, social, language, visual-spatial and practical reasoning skills, conducted or supervised by a child psychologist. These data will be used to conduct sensitivity analyses to test the hypothesis that linear growth failure either alone or in combination with additional factors identifies children with reduced neurodevelopment, who are therefore at risk of poor school attainment.

Study Type

Observational

Enrollment (Actual)

558

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, E1 4DG
        • Tower Hamlets GP Care Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 11 months (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Children randomly chosen from London borough of Tower Hamlets, based on Health Visitor records. All children will have height and weight measured as part of standard care by a Health Visitor or nursery nurse in the community, and caregivers are asked to complete a development questionnaire at age 2- 2.5 years as standard. Caregivers will be approached about taking part in the study and given information about what this involves.

Description

Inclusion Criteria:

  • Children aged 2-2.5 years, who live in Tower Hamlets and whose caregiver(s) are willing to provide written informed consent

Exclusion Criteria:

  • The caregiver does not provide written informed consent
  • The child is not able to stand for an accurate height measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability of the screening pilot
Time Frame: 3 years
Feasibility will be assessed using Bowen et al.'s '8 areas of focus': acceptability, demand, implementation, practicality, adaptation, integration, expansion and limited-efficacy testing. To achieve this, a mixed methods evaluation will be employed including qualitative data collection using focus groups with caregivers and health visitors as well as questionnaires distributed to all caregiver participants in the study and all health visitors involved in growth and development assessments. Quantitative data will be collected on: uptake of growth measurements; number of successful growth and development measurements; number of referrals successfully completed (i.e. referred to child growth clinic with participant attending one clinic appointment); number of participants consenting to identification of their child's anthropometric data from National Child Measurement Programme; and uptake of the phone app.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear Growth trajectory and child development
Time Frame: 3 years
This will be assessed by child height measurements at age 2-2.5 years, age 3-3.5 years, and age 4-5 years, in combination with target parental height. Parents who make use of the app will provide additional longitudinal growth measurements between age 2-5 years. All measurements will be entered into an algorithm, developed using data from two longitudinal United Kingdom cohorts (Millennium Cohort Study and Born in Bradford), which will identify children with poor linear growth based on absolute height, growth velocity and distance from target height.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Prof Andrew Prendergast, DPhil MRCPCH, Queen Mary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275717

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Growth Disorders

Subscribe