CClinicalTrials.gg
CompletedNCT04700904Updated Jan 27, 2025Results posted

PortionSize Study 1 Laboratory-based Evaluation)

An observational study in Dietary Habits, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Pennington Biomedical Research Center · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
43
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The objective is to test the accuracy and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals.

Read the detailed description

Accurately quantifying food intake is vital to promoting health and reducing chronic disease risk. Food intake encompasses energy intake, nutrient intake (macronutrients, micronutrients, vitamins, minerals), and intake of various food groups (e.g., fruits, vegetables), and thus reflects the nutritional status of individuals. Nutrition affects disease risk, including risk of developing obesity, diabetes, and cancer, all of which negatively affect the United States (U.S). Nonetheless, accurate assessment of food and nutrient intake has remained challenging, despite an improvement in methods. Self report methods, namely food records, are a mainstay of nutritional epidemiology research, with food recall being another popular method. These methods rely on the participant to accurately estimate portion size and, for food recall, remember what was consumed. The accuracy of these methods have been questioned and the problems with human recall have been comprehensively outlined. As a result, there remains a significant need for methods that are sufficiently accurate to provide researchers with good outcome data and to guide health promotion efforts.

The PortionSize™ app was designed by our laboratory to overcome the limitations outlined above, and to guide users to follow specific diets. PortionSize relies on users capturing images of their food selection and waste. Food intake data are immediately provided since the user relies on built in tools, including templates, to estimate portion size. However, despite promising early indications, the PortionSize app's validity has yet to be extensively tested. Determining the accuracy of PortionSize is vital before users can utilize the app to obtain immediate feedback about their food intake. We accordingly aim to test the validity of PortionSize in a controlled laboratory setting. We will also test the validity of the MyFitnessPal© app, which is similar to an electronic food record.

02

Conditions studied

  • Dietary Habits
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In context

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy participants ages 18 to 70 in the Baton Rouge, LA area.

Inclusion criteria

  • Male or female, age 18-70 years
  • Body mass index (BMI) 18.5 - 50
  • Ownership of an iPhone model 6s or later, which the participant is willing to use for the study
  • Access to Apple ID, password, and email address and willing to use them in the course of the study
  • Willing to use data and any accompanying charges as part of study participation
  • Willing to be re-contacted for future research and/or follow-up

Exclusion criteria

Exclusion Criteria:

  • Center employee
  • Any condition or circumstance that could impede study completion
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).

    The outcome variable was the difference between the criterion measure (directly weighed foods from a simulated lunch meal) and two apps: PortionSize and MyFitnessPal. The outcome measure for the PortionSize app was calculated as: energy intake values from PortionSize minus energy intake values from weighed foods. The outcome measure for the MyFitnessPal app was calculated as: energy intake values from MyFitnessPal minus energy intake values from weighed foods.

    Time frame: 2.5 hours

07

Results

Posted Jan 27, 2025

Participant flow

Participant flow — Overall Study
MilestoneMyFitnessPal (V1) PortionSize (V2)PortionSize (V1) MyFitnessPal (V2)
Started2122
Completed2121
Not completed01

Outcome measures

PrimaryDifference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).

The outcome variable was the difference between the criterion measure (directly weighed foods from a simulated lunch meal) and two apps: PortionSize and MyFitnessPal. The outcome measure for the PortionSize app was calculated as: energy intake values from PortionSize minus energy intake values from weighed foods. The outcome measure for the MyFitnessPal app was calculated as: energy intake values from MyFitnessPal minus energy intake values from weighed foods.

Time frame:
2.5 hours
Reported as:
Mean · kcal
Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).
kcalPortionSize AppMyFitnessPal App
Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).-150.1 ± 489.579.8 ± 583.3

Adverse events

Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants0/44 (0%)0/44 (0%)0/44 (0%)

Baseline characteristics

all 42 participants who completed the study

Age, Continuous
Age, Continuous(years)All Participants
Mean36.3 ± 16.6
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female23
Male19
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American10
White28
More than one race0
Unknown or Not Reported2
Weight
Weight(kg)All Participants
Mean81.5 ± 22.0
BMI
BMI(kg/m^2)All Participants
Mean28.2 ± 6.9
08

Study locations

1 site
  • Pennington Biomedical Research
    Baton Rouge, Louisiana 70808, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04700904
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Corby K. Martin (PBRC Professor, Director - Ingestive Behavior Laboratory, Pennington Biomedical Research Center) — Principal investigator
First posted
Jan 8, 2021
Start date
Feb 10, 2021
Primary completion
Oct 6, 2021
Completion
Dec 31, 2024
Results posted
Jan 27, 2025
Last update
Jan 27, 2025

Study contacts

John W Apolzan, PhD
principal investigator · Pennington Biomedical Research Center
Corby K Martin, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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