NCT05587816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

October 17, 2022

Results QC Date

December 8, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

Dietary Assessment

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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.

    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.

    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

    One study visit of ~ 2.5 hours

  • User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers

    Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Study Arms (1)

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

Device: Validation of the PortionSize app

Interventions

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.

Experimental

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Hanim Ecem Diktas
Organization
Pennington Biomedical Research Center

Study Officials

  • Hanim E Diktas, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

October 28, 2022

Primary Completion

March 6, 2023

Study Completion

March 13, 2023

Last Updated

April 15, 2026

Results First Posted

April 15, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations