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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05587816
• Collaborator: Blue Cross and Blue Shield of Louisiana Foundation (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.1
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Assessment	Device: Validation of the PortionSize app	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluating the Validity of a Novel Tool to Measure Children's Food Intake and Improve Health
• Actual Study Start Date: Oct 28, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

1. Estimation of energy intake (kcal) by children using the PortionSize app [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).

2. Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) by children using the PortionSize app [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).

3. Estimation of energy intake (kcal) by parents or caregivers using the PortionSize app [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.

4. Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) by parents or caregivers using the PortionSize app [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.

Secondary Outcome Measures

1. User satisfaction of the PortionSize app for recording food intake by children [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.

2. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Blue Cross and Blue Shield of Louisiana Foundation

Investigators

• Principal Investigator: Sanjoy Saha, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjoy Saha, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT05587816
• Other Study ID Numbers: PBRC 2022-031
• First Posted: Oct 20, 2022
• Last Update Posted: Nov 15, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sanjoy Saha, Principal Investigator, Pennington Biomedical Research Center: Dietary Assessment

Study Results

No Results Posted as of Nov 15, 2022