A Growth Artificial Intelligence Algorithm for leNgth and Weight Study (GAINS)

This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young children and b) test the accuracy of the AI algorithm by comparing the AI predicted length with the gold standard measured length. Images and videos will be collected by care givers and healthcare professionals, together with physical length measurements. These data will be used to train the AI algorithm and to explore potential improvements. Other data to be collected is user experience feedback.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight; Length

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Franciscus Gasthuis
• Poland
  • Wroclaw, Poland
    • Ginemedica
• Spain
  • Cadiz, Spain
    • Hospital Universitario Puerta del Mar
  • Jerez de la Frontera, Spain
    • Hospital Universitario de Jerez dela Frontera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Children aged 0 to 24 months.

Description

Inclusion Criteria:

1. Infants/young children aged 0 to 24 months old at enrolment;
2. Caregiver(s) have access to the internet and a smartphone or tablet to complete questionnaires, take images and videos, and upload these;
3. Written informed consent from one or both caregivers (according to local laws) or legally acceptable representative(s) aged ≥ 18 years at enrolment.

Exclusion Criteria:

1. Children unable to undergo length or weight measurements when applying standardized techniques recommended by the WHO (e.g. infants/children with structural abnormalities of the lower limbs or orthopaedic conditions (e.g. club foot, hip dysplasia)).
2. Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children 0-24 months; Children aged 0-24 months of age with no structural abnormalities of the lower limbs or orthopedic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy length AI	Accuracy of the Length AI vs length gold standard (WHO methodology with length board in cm) assessed using several different parameters: the bias (cm), agreement and reliability measures, mean absolute error (cm), mean absolute percentage error (%), percentiles of the absolute error (cm), and root mean square error (cm).	Date of enrolment, at baseline
Accuracy caregiver length	Accuracy of the caregiver measured length (own preferred methodology in cm) vs gold standard measured length (WHO methodology with length board in cm), assessed by same parameters as mentioned in the first primary outcome measure.	Date of enrolment, at baseline
Accuracy caregiver vs AI length	Accuracy of the caregiver measurements (self preferred methodology in cm) vs Length AI by same parameters as mentioned in the first primary outcome measure.	Date of enrolment, at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy weight AI	Accuracy of the Weight AI vs weight gold standard (WHO methodology with digital scale and tared weighing in kg) assessed using several different parameters: the bias (kg), agreement and reliability measures, mean absolute error (kg), mean absolute percentage error (%), percentiles of the absolute error (kg), and root mean square error (kg).	Date of enrolment, at baseline
Accuracy caregiver weight	Accuracy of the caregiver measured weight (self preferred methodology in kg) vs weight gold standard (WHO methodology with digital scale and tared weighing in kg), assessed using several different parameters as mentioned in the first secondary outcome measure.	Date of enrolment, at baseline
Ease of use tool	The ease of taking images and videos with the tool "GAINS app" on personal mobile device of the caregiver, assessed via a custom made user experience questionnaire.	Date of enrolment, at baseline
Acceptability tool	The expectation and acceptability of the tool "GAINS app" on a personal mobile device of the caregiver, assessed via a custom made user experience questionnaire.	Date of enrolment, at baseline

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): February 19, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: artificial intelligence; algorithm; weight; length
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight
• Other Study ID Numbers: 23REX0058267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not applicable due to the nature of the project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No