Short StatureNCT05829252
Testing the Feasibility of a Novel Growth Monitoring Smartphone App
An observational study of Short Stature and Growth Disorders, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to test the acceptability, feasibility, accuracy and precision of the 'GrowthMonitor' smartphone app in a pilot population. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Stature, Growth Disorders
- How many people
- 146 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2021to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients attending prearranged new and follow-up outpatient appointments at the Children's Hospital at Barts Health Trust, London. Participants will be recruited through convenience sampling in order to maximize recruitment efforts during the time of the study. Data on gender, age, and height will be collected.
Who may be able to join
- Children and young people (male and female) aged 1-18 yr receiving height measurements as part of their routine / prearranged attendance to a paediatric endocrinology or other paediatric out-patient appointment at Barts Health Trust.
- Participants require a smartphone to take part in the study.
Who cannot join
- Children under the age of 1 years
- Young people aged 16-18yr who lack capacity to consent
- Other individuals unable to reliably stand for an accurate height measurement e.g.
- individuals with severe disability and/or confined to a wheelchair
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test the acceptability, feasibility, accuracy and precision of the 'GrowthMonitor' smartphone app in a pilot population.
Read the detailed description
The GrowthMonitor app will calculate height data using smartphone images of children taken by parents or carers in the home at two or more set time points. The app will convert height data from the image to a numerical height measurement in centimeters and this will be transferred to a central database hosted on a secure UK based server with additional relevant demographic data (gender, ethnicity, weight, date of birth, and parents' height).
The height and demographic data are transferred with an anonymous identifier to a GDPR-approved secure database on a UK based server. Critically, patient images and children's names will not be transferred, and only authorized users will have access to the data stored within the secure database.
The app will display a virtual growth chart providing the patient with a digital history of the child's growth over time. BMI will also be calculated and plotted on an age- and gender-appropriate chart. Ultimately, users of the app will need to create an account using a username (email address) and password. We will use their email address so that password resets can be sent along with reminders or alerts about their account.
Child's height in relation to his/her parental heights as well as longitudinal growth data will be analyzed within the secure UK based web server using existing growth monitoring algorithms.
- Height compared to population-based height references (HSDS)
- Distance from target height (calculated from parental heights, THSDSDEV)
- HSDS change over time (ΔHSDS) -when more than one height measurement is available (taken >6 months apart)
Recorded heights will be compared with pre-established cut-off standards that define normal growth in an appropriate population. We envisage being able to incorporate ethnicity-matched reference population data as the app evolves. An automated outcome will be returned to the parent/carer, via in app notification or email, and will offer advice, for example, confirming normal growth or recommending appropriate medical contact.
Data will be stored in such a way that users can sync their old growth measurements on to any new / replacement smartphone handset and also 'sync' any measurements taken offline.
An accurate standing height measurement will be obtained using a calibrated stadiometer during a patient clinic visit. This 'gold standard' height measurement will be performed by a trained member of the research team and documented. This will be used to compare with the height obtained by the growth monitoring app in the clinic and subsequently at home.
- Conditions
- Short Stature, Growth Disorders
- Keywords
- Height measurement, Child height, Short stature, Smartphone App, Digital Health
- Medical subject headings
- Dwarfism, Growth Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability
Inter- and intra-rater reproducibility of the GrowthMonitor app
Measured: At baseline
Agreement
Agreement between the GrowthMonitor app and wall-fixed stadiometer
Measured: At baseline
Secondary outcomes (1)
Usability
Participants rate the usability of the GrowthMonitor app on a multiple-question 5-point Likert scale
Measured: At 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start18 Mar 2021
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Storr, PhD, Principal investigator, Queen Mary University, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829252
- Sponsor's protocol ID
- 286683
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Novel Growth Monitoring Smartphone App
- ClinicalTrials.gov ID
- NCT05829252
- Acronym / sponsor ID
- 286683
- Conditions
- Short Stature, Growth Disorders
- Keywords
- Height measurement, Child height, Short stature, Smartphone App, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the acceptability, feasibility, accuracy and precision of the 'GrowthMonitor' smartphone app in a pilot population.
Detailed description
The GrowthMonitor app will calculate height data using smartphone images of children taken by parents or carers in the home at two or more set time points. The app will convert height data from the image to a numerical height measurement in centimeters and this will be transferred to a central database hosted on a secure UK based server with additional relevant demographic data (gender, ethnicity, weight, date of birth, and parents' height).
The height and demographic data are transferred with an anonymous identifier to a GDPR-approved secure database on a UK based server. Critically, patient images and children's names will not be transferred, and only authorized users will have access to the data stored within the secure database.
The app will display a virtual growth chart providing the patient with a digital history of the child's growth over time. BMI will also be calculated and plotted on an age- and gender-appropriate chart. Ultimately, users of the app will need to create an account using a username (email address) and password. We will use their email address so that password resets can be sent along with reminders or alerts about their account.
Child's height in relation to his/her parental heights as well as longitudinal growth data will be analyzed within the secure UK based web server using existing growth monitoring algorithms.
- Height compared to population-based height references (HSDS)
- Distance from target height (calculated from parental heights, THSDSDEV)
- HSDS change over time (ΔHSDS) -when more than one height measurement is available (taken >6 months apart)
Recorded heights will be compared with pre-established cut-off standards that define normal growth in an appropriate population. We envisage being able to incorporate ethnicity-matched reference population data as the app evolves. An automated outcome will be returned to the parent/carer, via in app notification or email, and will offer advice, for example, confirming normal growth or recommending appropriate medical contact.
Data will be stored in such a way that users can sync their old growth measurements on to any new / replacement smartphone handset and also 'sync' any measurements taken offline.
An accurate standing height measurement will be obtained using a calibrated stadiometer during a patient clinic visit. This 'gold standard' height measurement will be performed by a trained member of the research team and documented. This will be used to compare with the height obtained by the growth monitoring app in the clinic and subsequently at home.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients attending prearranged new and follow-up outpatient appointments at the Children's Hospital at Barts Health Trust, London. Participants will be recruited through convenience sampling in order to maximize recruitment efforts during the time of the study. Data on gender, age, and height will be collected.
Key inclusion criteria (2 listed)
- Children and young people (male and female) aged 1-18 yr receiving height measurements as part of their routine / prearranged attendance to a paediatric endocrinology or other paediatric out-patient appointment at Barts Health Trust.
- Participants require a smartphone to take part in the study.
Key exclusion criteria (4 listed)
- Children under the age of 1 years
- Young people aged 16-18yr who lack capacity to consent
- Other individuals unable to reliably stand for an accurate height measurement e.g.
- individuals with severe disability and/or confined to a wheelchair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability
Time frame: At baseline
Inter- and intra-rater reproducibility of the GrowthMonitor app
Agreement
Time frame: At baseline
Agreement between the GrowthMonitor app and wall-fixed stadiometer
1 secondary outcome
Usability
Time frame: At 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Storr, PhD principal investigator
Queen Mary University, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Stature and Growth Disorders, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.