- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05587816
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
Conditions
Intervention / Treatment
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
- Name: Sanjoy Saha, PhD
- Phone Number: 225 763-2854
- Email: sanjoy.saha@pbrc.edu
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
|
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.
Collaborators
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
Keywords
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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