Trial Outcomes & Findings for Validity of the PortionSize App to Measure Children's Food Intake (NCT NCT05587816)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

One study visit of ~ 2.5 hours

Results posted on

2026-04-15

Participant Flow

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.

Screening and enrollment were conducted at Pennington Biomedical Research Center. * Dyads enrolled: 31 * Children included: 31 * Caregivers/parents included: 31 - Among 31 parents, 21 were unique, as nine had a second child who participated in the study. * No randomization; single group assignment. * Intervention: training on and use of the PortionSize app by children and by caregivers/parents to log children's meals; validation in clinic and free-living use at home.

Participant milestones

Participant milestones
Measure	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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
Overall Study STARTED	31
Overall Study Children Included	31
Overall Study Caregivers/Parents Included	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Children n=30 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home. Parents/caregivers assisted with reporting and training but were not counted as participants. Enrollment and Participant Flow therefore reflect children only. In total, 31 children were enrolled (Started), and 30 children completed the study. Baseline analyses were performed only for child participants. Caregivers/parents assisted with training and meal logging but were not analyzed as participants, and no baseline data were collected for the caregiver/parent group. Accordingly, baseline characteristics are reported only for the Children.
Age, Continuous	9.6 years STANDARD_DEVIATION 1.8 • n=193 Participants
Sex: Female, Male Female	13 Participants n=193 Participants
Sex: Female, Male Male	17 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	1 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	8 Participants n=193 Participants
Race (NIH/OMB) White	21 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Region of Enrollment United States	30 participants n=193 Participants
BMI percentile	55.9 percentile STANDARD_DEVIATION 32.3 • n=193 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated 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	717.9 kcal Standard Deviation 284.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App	0.5 cup equivalence - fruit Standard Deviation 0.7

PRIMARY outcome

Timeframe: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Population: The study consisted of two phases. In Phase 1, children completed all study procedures. In Phase 2, parents completed the procedures in a home setting. For the current analysis, 28 parents successfully completed the dietary estimation tasks during Phase 2.

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.

Outcome measures

Outcome measures
Measure	Experimental n=28 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated 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/Day) by Parents or Caregivers Using the PortionSize App	871.7 kcal/day Standard Deviation 410.3

PRIMARY outcome

Timeframe: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Population: The study consisted of two phases. In Phase 1, children completed all study procedures. In Phase 2, parents completed the procedures in a home setting. For the current analysis, 28 parents successfully completed the dietary estimation tasks during Phase 2.

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.

Outcome measures

Outcome measures
Measure	Experimental n=28 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App	0.4 cup equivalence - fruit Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome.

Outcome measures

Outcome measures
Measure	Experimental n=30 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
User Satisfaction of the PortionSize App for Recording Food Intake by Children	4.78 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Population: The study consisted of two phases. In Phase 1, children completed all study procedures. In Phase 2, parents completed the procedures in a home setting. For the current analysis, 28 parents successfully completed the dietary estimation tasks during Phase 2.

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.

Outcome measures

Outcome measures
Measure	Experimental n=28 Participants * 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 Validation of the PortionSize app: The investigators recruited 31 dyads (31 children aged 7-12 years old and parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers were trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children used the PortionSize app and estimated food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children did not consume the simulated meals. Children's parents or caregivers also used the PortionSize app and estimated the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers	4.83 score on a scale Standard Error 1.14

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hanim Ecem Diktas

Pennington Biomedical Research Center

Phone: +1 (225) 763-2832

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place