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

August 3, 2023 updated by: Hanim Diktas, Pennington Biomedical Research Center

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

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 Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One study visit of ~ 2.5 hours
Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) 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).
One study visit of ~ 2.5 hours
Estimation of energy intake (kcal) 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.
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, vegetable, grain, protein, and dairy) 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.
Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User satisfaction of the PortionSize app for recording food intake by children
Time Frame: One study visit of ~ 2.5 hours
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 value is 1 and the maximum value is 6 for each question and higher scores indicate a higher outcome.
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
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 value is 1 and the maximum value is 6 for each question and higher scores indicate a higher outcome.
Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hanim E Diktas, PhD, Pennington Biomedical Research Center

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)

October 28, 2022

Primary Completion (Actual)

March 6, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 2022-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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