An interventional study of Validation of the PortionSize app in Nutritional Assessment, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Other
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.
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.
Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
* 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.
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).
Time frame: 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).
Time frame: 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.
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
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.
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
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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
Time frame: One study visit of ~ 2.5 hours
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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
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
Children were enrolled in child-parent dyads. Parents/caregivers assisted with meal logging and training but were not analyzed as outcome participants. Participant Flow counts represent dyads; additional milestones below break down the numbers of children and caregivers included and how they progressed.
| Milestone | Experimental |
|---|---|
| Started | 31 |
| Children included | 31 |
| Caregivers/parents included | 31 |
| Completed | 30 |
| Not completed | 1 |
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).
| kcal | Experimental |
|---|---|
| Estimation of Energy Intake (kcal) by Children Using the PortionSize App | 717.9 ± 284.6 |
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).
| cup equivalence - fruit | Experimental |
|---|---|
| Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App | 0.5 ± 0.7 |
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.
| kcal/day | Experimental |
|---|---|
| Estimation of Energy Intake (kcal/Day) by Parents or Caregivers Using the PortionSize App | 871.7 ± 410.3 |
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.
| cup equivalence - fruit | Experimental |
|---|---|
| Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App | 0.4 ± 0.7 |
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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
| score on a scale | Experimental |
|---|---|
| User Satisfaction of the PortionSize App for Recording Food Intake by Children | 4.78 ± 1.27 |
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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.
| score on a scale | Experimental |
|---|---|
| User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers | 4.83 ± 1.14 |
Collected over Phase 1: Approximately 2.5 hours during in-laboratory testing. Phase 2: Approximately 2 consecutive days of data collection in the home setting.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Experimental: Children |
|---|---|
| Mean | 9.6 ± 1.8 |
| Sex: Female, Male(Participants) | Experimental: Children |
|---|---|
| Female | 13 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Experimental: Children |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Experimental: Children |
|---|---|
| United States | 30 |
| BMI percentile(percentile) | Experimental: Children |
|---|---|
| Mean | 55.9 ± 32.3 |
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Plan to share: No — 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.
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Pennington Biomedical Research Center