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

Nutritional Assessment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05587816
• Other study ID #: PBRC 2022-031
• Status: Completed
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: August 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 13, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Assessment

Intervention

Device:
• Validation of 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Blue Cross and Blue Shield of Louisiana Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) 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
Primary	Estimation of energy intake (kcal) 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
Primary	Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) 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	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 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
Secondary	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 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