NCT05419336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

June 10, 2022

Last Update Submit

May 15, 2025

Conditions

Keywords

StuntingStunted GrowthGrowth Screening

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the screening pilot

    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 Outcomes (1)

  • Linear Growth trajectory and child development

    3 years

Eligibility Criteria

Age24 Months - 30 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tower Hamlets GP Care Group

London, E1 4DG, United Kingdom

Location

Related Publications (7)

  • Ahmed ML, Allen AD, Sharma A, Macfarlane JA, Dunger DB. Evaluation of a district growth screening programme: the Oxford Growth Study. Arch Dis Child. 1993 Sep;69(3):361-5. doi: 10.1136/adc.69.3.361.

    PMID: 7692826BACKGROUND
  • Green AA, MacFarlane JA. Method for the earlier recognition of abnormal stature. Arch Dis Child. 1983 Jul;58(7):535-7. doi: 10.1136/adc.58.7.535.

    PMID: 6870335BACKGROUND
  • Rogol AD, Hayden GF. Etiologies and early diagnosis of short stature and growth failure in children and adolescents. J Pediatr. 2014 May;164(5 Suppl):S1-14.e6. doi: 10.1016/j.jpeds.2014.02.027.

    PMID: 24731744BACKGROUND
  • Maghnie M, Labarta JI, Koledova E, Rohrer TR. Short Stature Diagnosis and Referral. Front Endocrinol (Lausanne). 2018 Jan 11;8:374. doi: 10.3389/fendo.2017.00374. eCollection 2017.

    PMID: 29375479BACKGROUND
  • Sankilampi U, Saari A, Laine T, Miettinen PJ, Dunkel L. Use of electronic health records for automated screening of growth disorders in primary care. JAMA. 2013 Sep 11;310(10):1071-2. doi: 10.1001/jama.2013.218793. No abstract available.

    PMID: 24026604BACKGROUND
  • Jelenkovic A, Sund R, Hur YM, Yokoyama Y, Hjelmborg JV, Moller S, Honda C, Magnusson PK, Pedersen NL, Ooki S, Aaltonen S, Stazi MA, Fagnani C, D'Ippolito C, Freitas DL, Maia JA, Ji F, Ning F, Pang Z, Rebato E, Busjahn A, Kandler C, Saudino KJ, Jang KL, Cozen W, Hwang AE, Mack TM, Gao W, Yu C, Li L, Corley RP, Huibregtse BM, Derom CA, Vlietinck RF, Loos RJ, Heikkila K, Wardle J, Llewellyn CH, Fisher A, McAdams TA, Eley TC, Gregory AM, He M, Ding X, Bjerregaard-Andersen M, Beck-Nielsen H, Sodemann M, Tarnoki AD, Tarnoki DL, Knafo-Noam A, Mankuta D, Abramson L, Burt SA, Klump KL, Silberg JL, Eaves LJ, Maes HH, Krueger RF, McGue M, Pahlen S, Gatz M, Butler DA, Bartels M, van Beijsterveldt TC, Craig JM, Saffery R, Dubois L, Boivin M, Brendgen M, Dionne G, Vitaro F, Martin NG, Medland SE, Montgomery GW, Swan GE, Krasnow R, Tynelius P, Lichtenstein P, Haworth CM, Plomin R, Bayasgalan G, Narandalai D, Harden KP, Tucker-Drob EM, Spector T, Mangino M, Lachance G, Baker LA, Tuvblad C, Duncan GE, Buchwald D, Willemsen G, Skytthe A, Kyvik KO, Christensen K, Oncel SY, Aliev F, Rasmussen F, Goldberg JH, Sorensen TI, Boomsma DI, Kaprio J, Silventoinen K. Genetic and environmental influences on height from infancy to early adulthood: An individual-based pooled analysis of 45 twin cohorts. Sci Rep. 2016 Jun 23;6:28496. doi: 10.1038/srep28496.

    PMID: 27333805BACKGROUND
  • Hauer NN, Popp B, Schoeller E, Schuhmann S, Heath KE, Hisado-Oliva A, Klinger P, Kraus C, Trautmann U, Zenker M, Zweier C, Wiesener A, Abou Jamra R, Kunstmann E, Wieczorek D, Uebe S, Ferrazzi F, Buttner C, Ekici AB, Rauch A, Sticht H, Dorr HG, Reis A, Thiel CT. Clinical relevance of systematic phenotyping and exome sequencing in patients with short stature. Genet Med. 2018 Jun;20(6):630-638. doi: 10.1038/gim.2017.159. Epub 2017 Oct 12.

    PMID: 29758562BACKGROUND

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Prof Andrew Prendergast, DPhil MRCPCH

    Queen Mary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

July 15, 2022

Primary Completion

March 30, 2024

Study Completion

September 30, 2024

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations