CGDEL: Child Growth and Development in East London

Sponsor
Queen Mary University of London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05419336
Collaborator
Barts & The London NHS Trust (Other), Child Growth Foundation (Other), The Patients Association (Other)
630
32.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    630 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Child Growth and Development in East London
    Anticipated Study Start Date :
    Jul 15, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility and acceptability of the screening pilot [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.

    Secondary Outcome Measures

    1. Linear Growth trajectory and child development [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Months to 30 Months
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Queen Mary University of London
    • Barts & The London NHS Trust
    • Child Growth Foundation
    • The Patients Association

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Queen Mary University of London
    ClinicalTrials.gov Identifier:
    NCT05419336
    Other Study ID Numbers:
    • 275717
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Queen Mary University of London
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2022