Nutritional AssessmentNCT05587816

Validity of the PortionSize App to Measure Children's Food Intake

A study testing Validation of the PortionSize app in people with Nutritional Assessment, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers. Read more about this study

Who is it for?: Ages 7 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Nutritional Assessment
What is being tested?: Validation of the PortionSize app
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2022to 13 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female
Children (7-12 years) and their parents or caregivers (18-62 years)
Parents who have Willingness to use the PortionSize app to estimate the intake of their child food intake (normal/regular diet) from at least a snack and a meal of child for two consecutive days
Have iPhone (version 6 or above) and an operable Apple ID, password, and email address, and able to use iPhone

Who cannot join

Any condition or circumstance that could impede study completion
Child who is a very choosy eater or has a very limited food choice

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: Evaluating the Validity of a Novel Tool to Measure Children's Food Intake and Improve Health

The purpose of this study is to assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers.

Read the detailed description

The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.

Conditions: Nutritional Assessment
Being tested: Validation of the PortionSize app
Keywords: Dietary Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Validation of the PortionSize appDevice
The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.

Study groups in NCT05587816
Study group	Role	What they receive
Experimental	Experimental	* Training and use of the PortionSize app by children and parents or caregivers * Using the PortionSize app at the clinic of Pennington Biomedical Research Center and at home (free-living condition) * Rating the satisfaction of using the PortionSize app Receives: Device: Validation of the PortionSize app

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimation of Energy Intake (kcal) by Children Using the PortionSize App
Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of energy intake from the PortionSize app compared to estimations of energy intake from the weighed meals (the criterion measure).
Measured: One study visit of ~ 2.5 hours
Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App
Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of intake of food group servings from the PortionSize app compared to estimations of food group servings from the weighed meals (the criterion measure).
Measured: One study visit of ~ 2.5 hours
Estimation of Energy Intake (kcal/Day) by Parents or Caregivers Using the PortionSize App
Percent mean error and Bland-Altman analysis will be performed to assess errors in estimating energy intake using the PortionSize app compared to estimations of energy measured by expert raters via food photography analysis.
Measured: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home
Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App
Percent mean error and Bland-Altman analysis will be performed to assess errors in intake of food group servings using the PortionSize app compared to estimations of food group servings measured by expert raters via food photography analysis.
Measured: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Secondary outcomes (2)

User Satisfaction of the PortionSize App for Recording Food Intake by Children
After completing assessment of food at clinic, children will complete a Likert scale-based survey questionnaire (User Satisfaction questionnaire). The investigators updated a 10-question user satisfaction survey that has been administered in prior studies to quantify satisfaction, ease of use, and adequacy of training for mobile app. The minimum score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
Measured: One study visit of ~ 2.5 hours
User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers
After completing assessment of child's food intake, parents or caregivers will complete a Likert scale-based survey questionnaire (User Satisfaction questionnaire). . The investigators updated a 10-question user satisfaction survey that has been administered in prior studies to quantify satisfaction, ease of use, and adequacy of training for mobile app. The minimum score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
Measured: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202213 Mar 2023

First posted20 Oct 2022
Study start28 Oct 2022
Primary completion6 Mar 2023
Study completion13 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nutritional AssessmentStudies of the same condition, open and under way.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05587816
Sponsor's protocol ID: PBRC 2022-031
Status last verified: Mar 2026
First submitted: 17 Oct 2022
Last updated: 15 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Any identifiers might be removed from the participants identifiable information and after the removal, the information could be used for future research studies or given to another investigator for future research without additional informed consent from the subject or legally authorized representative.

Publications

Saha S, Diktas HE, Lozano CP, Staiano AE, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize App for Assessing Children's Dietary Intake: Results From a Pilot Study Conducted in Controlled and Free-Living Settings. Pediatr Obes. 2026 Mar;21(3):e70102. doi: 10.1111/ijpo.70102.
PubMed 41807093

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Validity of a Novel Tool to Measure Children's Food Intake and Improve Health
ClinicalTrials.gov ID: NCT05587816
Acronym / sponsor ID: PBRC 2022-031
Conditions: Nutritional Assessment
Keywords: Dietary Assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Blue Cross Blue Shield
Study start: 28 Oct 2022 (actual)
Primary completion: 6 Mar 2023 (actual)
Study completion: 13 Mar 2023 (actual)
First posted: 20 Oct 2022 (actual)
Results: Posted 15 Apr 2026

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 assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Device: Validation of the PortionSize app* Training and use of the PortionSize app by children and parents or caregivers * Using the PortionSize app at the clinic of Pennington Biomedical Research Center and at home (free-living condition) * Rating the satisfaction of using the PortionSize app

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female
Children (7-12 years) and their parents or caregivers (18-62 years)
Parents who have Willingness to use the PortionSize app to estimate the intake of their child food intake (normal/regular diet) from at least a snack and a meal of child for two consecutive days
Have iPhone (version 6 or above) and an operable Apple ID, password, and email address, and able to use iPhone

Key exclusion criteria (2 listed)

Any condition or circumstance that could impede study completion
Child who is a very choosy eater or has a very limited food choice

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
Validation of the PortionSize appThe investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.	Device	Experimental

Primary outcome

Estimation of Energy Intake (kcal) by Children Using the PortionSize App
Time frame: One study visit of ~ 2.5 hours
Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of energy intake from the PortionSize app compared to estimations of energy intake from the weighed meals (the criterion measure).
Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App
Time frame: One study visit of ~ 2.5 hours
Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of intake of food group servings from the PortionSize app compared to estimations of food group servings from the weighed meals (the criterion measure).
Estimation of Energy Intake (kcal/Day) by Parents or Caregivers Using the PortionSize App
Time frame: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home
Percent mean error and Bland-Altman analysis will be performed to assess errors in estimating energy intake using the PortionSize app compared to estimations of energy measured by expert raters via food photography analysis.
Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App
Time frame: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home
Percent mean error and Bland-Altman analysis will be performed to assess errors in intake of food group servings using the PortionSize app compared to estimations of food group servings measured by expert raters via food photography analysis.

2 secondary outcomes

User Satisfaction of the PortionSize App for Recording Food Intake by Children
Time frame: One study visit of ~ 2.5 hours
User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers
Time frame: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Results and safety

Results posted to the registry on 15 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	31	30

Primary outcome: Estimation of Energy Intake (kcal) by Children Using the PortionSize App

Time frame: One study visit of ~ 2.5 hours. Mean (Standard Deviation). Unit: kcal

Measure	Experimental n = 30
Value	717.9 (284.6)

Experimental: p = 0.022, Two One-side T-Test (TOST) method

Primary outcome: Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App

Time frame: One study visit of ~ 2.5 hours. Mean (Standard Deviation). Unit: cup equivalence - fruit

Measure	Experimental n = 30
Value	0.5 (0.7)

Experimental: p = 0.45, Two One-side T-Test (TOST) method

Primary outcome: Estimation of Energy Intake (kcal/Day) by Parents or Caregivers Using the PortionSize App

Time frame: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home. Mean (Standard Deviation). Unit: kcal/day

Measure	Experimental n = 28
Value	871.7 (410.3)

Experimental: p = 0.24, Two One-side T-Test (TOST) method

Population analysed: The study consisted of two phases. In Phase 1, children completed all study procedures. In Phase 2, parents completed the procedures in a home setting. For the current analysis, 28 parents successfully completed the dietary estimation tasks during Phase 2.

Primary outcome: Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App

Time frame: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home. Mean (Standard Deviation). Unit: cup equivalence - fruit

Measure	Experimental n = 28
Value	0.4 (0.7)

Experimental: p = 0.25, Two One-side T-Test (TOST) method

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase 1: Approximately 2.5 hours during in-laboratory testing. Phase 2: Approximately 2 consecutive days of data collection in the home setting.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41807093Saha S, Diktas HE, Lozano CP, Staiano AE, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize App for Assessing Children's Dietary Intake: Results From a Pilot Study Conducted in Controlled and Free-Living Settings. Pediatr Obes. 2026 Mar;21(3):e70102. doi: 10.1111/ijpo.70102.
Individual participant dataSharing planned: No. Any identifiers might be removed from the participants identifiable information and after the removal, the information could be used for future research studies or given to another investigator for future research without additional informed consent from the subject or legally authorized representative.

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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.

Hanim E Diktas, PhD principal investigator

Pennington Biomedical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Validation of the PortionSize app in people with Nutritional Assessment, run by Pennington Biomedical Research Center 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 4 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: finished, as of the sponsor's last update on 15 Apr 2026. 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?

Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Estimation of Energy Intake (kcal) by Children Using the PortionSize App (time frame: One study visit of ~ 2.5 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05587816, which also lists 1 linked publication.

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 Apr 2026.