HealthyNCT05034913
Digital Photography to Estimate Anthropometric Measurements in Children
A study testing Digital photography measurements in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if photos taken from home can accurately let physicians know the height, abdominal circumference, and wrist circumference of children, and how these measurements relate to in-person measurements. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Digital photography measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 28 Sep 2021
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children age 2-18 years old.
- Seen on Mayo 16 for an outpatient clinic appointment.
Who cannot join
- Participant unable to stand for stadiometer height
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Use of Digital Photography to Estimate Anthropometric Measurements in Children
The purpose of this study is to see if photos taken from home can accurately let physicians know the height, abdominal circumference, and wrist circumference of children, and how these measurements relate to in-person measurements.
Read the detailed description
This study will occur in two distinct parts. Children age 2-18 who present to Mayo for an outpatient clinic appointment will be considered for participation in the study. Patients eligible for the study will receive a portal message the day prior to their appointment informing them of the option to take place in the study as well as instructions on how to measure height, abdominal circumference, and wrist circumference, and how to obtain and submit digital photographs. Participants can submit photographs and home measurements either before or after the in clinic measurements and photographs have been obtained. Those willing to participate will sign a parental consent form and a child assent form. Consent and assent forms can be seen in the supplemental documents.
At Home Participants will be given written instructions asking for 2 photographs to be submitted via the patient portal and for measurements of height, abdominal circumference, and wrist circumference to be obtained using a home tape measure. Detailed patient instructions will be shared.
Study Visit
Traditional Anthropometric Measurements Participant will have a height measurement using a calibrated stadiometer, a weight measurement taken on a scale, a waist circumference taken at the umbilicus, and a wrist circumference will be taken while seated on the dominant wrist over the Lister tubercle of the radius and over the distal ulna. Participants 5 years of age and older who are 90cm and greater will have body composition assessed by impedance. Bioelectrical impedance is not in any way uncomfortable and does not expose the participant to any radiation. Participant measurements will be recorded in the patient record and a secure excel document or in RedCap. Recruited patient's medical record number (MRN) will be documented in a secure excel document or in RedCap.
Digital Photography Measurements The participant will be instructed to take off any thick outer layers and leave on shirt and pants. Tops will be gathered to make cloth tight to body. The participant will stand next to an 8 ½" x 11" piece of paper taped to a wall, to use as a reference for linear regression calculations. The participant will have a photograph taken in the "Frankfurt plane" with lower border of the eyes in line with the external ear canal, palms facing forward and arms to the side, while taking a deep breath at the time of the photograph to have optimal stretching. A photograph will be taken from the side in the sagittal plane with palms facing down and arms outstretched in front of the patient while taking a deep breath at the time of the photograph for optimal stretching. These photos will be taken by a trained member of the research team.
- Conditions
- Healthy
- Being tested
- Digital photography measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital photography measurementsOther
The participant will be instructed to take off any thick outer layers and leave on shirt and pants. Tops will be gathered to make cloth tight to body. The participant will stand next to an 8 ½" x 11" piece of paper taped to a wall, to use as a reference for linear regression calculations.
| Study group | Role | What they receive |
|---|---|---|
| Photography to Measure Children's Height, Wrist Circumference, and Abdominal Circumference | Experimental | Subjects will be given instructions on how to take two photographs at home and submit them securely. Subjects will also be given instructions on how to measure height, wrist circumference, and waist circumference and submit this data to the research team. Receives: Other: Digital photography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Measured in cm
Measured: 1 day
Abdominal circumference
Measured in cm
Measured: 1 day
Wrist circumference
Measured in cm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start30 Aug 2021
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Why it stopped: Initial data analysis prior to full enrollment showed that concept was not valid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siobhan T. Pittock, Mayo Clinic
- Investigators
- Siobhan Pittock, M.B., B.Ch,, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034913
- Sponsor's protocol ID
- 20-011901
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Digital Photography to Estimate Anthropometric Measurements in Children
- ClinicalTrials.gov ID
- NCT05034913
- Acronym / sponsor ID
- 20-011901
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial data analysis prior to full enrollment showed that concept was not valid.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 5 Sep 2021 (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 purpose of this study is to see if photos taken from home can accurately let physicians know the height, abdominal circumference, and wrist circumference of children, and how these measurements relate to in-person measurements.
Detailed description
This study will occur in two distinct parts. Children age 2-18 who present to Mayo for an outpatient clinic appointment will be considered for participation in the study. Patients eligible for the study will receive a portal message the day prior to their appointment informing them of the option to take place in the study as well as instructions on how to measure height, abdominal circumference, and wrist circumference, and how to obtain and submit digital photographs. Participants can submit photographs and home measurements either before or after the in clinic measurements and photographs have been obtained. Those willing to participate will sign a parental consent form and a child assent form. Consent and assent forms can be seen in the supplemental documents.
At Home Participants will be given written instructions asking for 2 photographs to be submitted via the patient portal and for measurements of height, abdominal circumference, and wrist circumference to be obtained using a home tape measure. Detailed patient instructions will be shared.
Study Visit
Traditional Anthropometric Measurements Participant will have a height measurement using a calibrated stadiometer, a weight measurement taken on a scale, a waist circumference taken at the umbilicus, and a wrist circumference will be taken while seated on the dominant wrist over the Lister tubercle of the radius and over the distal ulna. Participants 5 years of age and older who are 90cm and greater will have body composition assessed by impedance. Bioelectrical impedance is not in any way uncomfortable and does not expose the participant to any radiation. Participant measurements will be recorded in the patient record and a secure excel document or in RedCap. Recruited patient's medical record number (MRN) will be documented in a secure excel document or in RedCap.
Digital Photography Measurements The participant will be instructed to take off any thick outer layers and leave on shirt and pants. Tops will be gathered to make cloth tight to body. The participant will stand next to an 8 ½" x 11" piece of paper taped to a wall, to use as a reference for linear regression calculations. The participant will have a photograph taken in the "Frankfurt plane" with lower border of the eyes in line with the external ear canal, palms facing forward and arms to the side, while taking a deep breath at the time of the photograph to have optimal stretching. A photograph will be taken from the side in the sagittal plane with palms facing down and arms outstretched in front of the patient while taking a deep breath at the time of the photograph for optimal stretching. These photos will be taken by a trained member of the research team.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photography to Measure Children's Height, Wrist Circumference, and Abdominal Circumference | Experimental | Other: Digital photography measurementsSubjects will be given instructions on how to take two photographs at home and submit them securely. Subjects will also be given instructions on how to measure height, wrist circumference, and waist circumference and submit this data to the research team. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children age 2-18 years old.
- Seen on Mayo 16 for an outpatient clinic appointment.
Key exclusion criteria (2 listed)
- Participant unable to stand for stadiometer height
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital photography measurementsThe participant will be instructed to take off any thick outer layers and leave on shirt and pants. Tops will be gathered to make cloth tight to body. The participant will stand next to an 8 ½" x 11" piece of paper taped to a wall, to use as a reference for linear regression calculations. | Other | Photography to Measure Children's Height, Wrist Circumference, and Abdominal Circumference |
Primary outcome
Height
Time frame: 1 day
Measured in cm
Abdominal circumference
Time frame: 1 day
Measured in cm
Wrist circumference
Time frame: 1 day
Measured in cm
Results and safety
The study was stopped early (reason given: Initial data analysis prior to full enrollment showed that concept was not valid.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Siobhan Pittock, M.B., B.Ch, principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital photography measurements in people with Healthy, run by Mayo Clinic at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 15 Sep 2023. 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 States. 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 was stopped early (reason given: Initial data analysis prior to full enrollment showed that concept was not valid.). Results are not available in the source record.
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?
Height (time frame: 1 day). The study lists 3 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 15 Sep 2023.