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| Name | Class |
|---|---|
| Blue Cross Blue Shield | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of the PortionSize app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). | 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. | 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. | Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanim E Diktas, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41807093 | Derived | Saha S, Diktas HE, Lozano CP, Staiano AE, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize App for Assessing Children's Dietary Intake: Results From a Pilot Study Conducted in Controlled and Free-Living Settings. Pediatr Obes. 2026 Mar;21(3):e70102. doi: 10.1111/ijpo.70102. |
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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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Screening and enrollment were conducted at Pennington Biomedical Research Center.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental |
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Children |
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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | kcal | One study visit of ~ 2.5 hours |
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Phase 1: Approximately 2.5 hours during in-laboratory testing. Phase 2: Approximately 2 consecutive days of data collection in the home setting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental |
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. Therefore Adverse Event group reflect children only. In total, 31 children were enrolled (Started), and 30 children completed the study. Adverse events were assessed and reported only for child participants. Caregivers/parents assisted with training and meal logging but were not analysis participants, and no adverse event data were collected for the caregiver/parent group. Accordingly, adverse events were only assessed and reported for the Children. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hanim Ecem Diktas | Pennington Biomedical Research Center | +1 (225) 763-2832 | hanim.diktas@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol with initial PI | Aug 24, 2022 | Dec 8, 2025 | Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol with changed PI | May 5, 2023 | Dec 8, 2025 | Prot_001.pdf |
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| 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. | Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI percentile | Mean | Standard Deviation | percentile |
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| Primary | 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). | Posted | Mean | Standard Deviation | cup equivalence - fruit | One study visit of ~ 2.5 hours |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | kcal/day | Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | cup equivalence - fruit | Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home |
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| 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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome. | Posted | Mean | Standard Deviation | score on a scale | One study visit of ~ 2.5 hours |
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| 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 score is 1 and the maximum score is 6 for each question and higher scores indicate a higher outcome. | 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. | Posted | Mean | Standard Error | score on a scale | Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home |
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| 30 |
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| 30 |
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| 30 |
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