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

May 20, 2026 updated by: Nutricia Research
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy length AI
Time Frame: Date of enrolment, at baseline
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
Time Frame: Date of enrolment, at baseline
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
Time Frame: Date of enrolment, at baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy weight AI
Time Frame: Date of enrolment, at baseline
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
Time Frame: Date of enrolment, at baseline
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
Time Frame: Date of enrolment, at baseline
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
Time Frame: Date of enrolment, at baseline
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia Research

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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