NCT05166226

Brief Summary

The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions. Participants will use PortionSize™ and MyFitnessPal apps in separate periods to test the accuracy of the respective apps.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

December 8, 2021

Results QC Date

November 13, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy (Kilocalorie or kcal) Intake

    The primary analyses assessing equivalence between PortionSize™ and the criterion measure (and MyFitnessPal and the criterion measures) will rely on equivalence testing using the Two One-side T-test (TOST) method. The null hypothesis of an equivalence tests is that the means are nonequivalent, i.e., the confidence interval of the mean of the test condition exceeds the pre-specified error bound. The alternative hypothesis is that the means are equivalent, and the mean difference between the experimental method and gold standard is hypothesized to be zero. Differences in error from PortionSize™ compared to error from MyFitnessPal will be assessed using dependent samples t-tests, with error calculated as the difference between each experimental method and the criterion variable (e.g., energy intake values from PortionSize™ minus energy intake values from weighed foods). These procedures will also produce results indicating if the error from each method differs from zero.

    Mean daily energy intake averaged across 3 day free-living period of each PortionSize app and MyFitnessPal app intervention.

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants ages 18 to 62 in the Baton Rouge, LA area

You may qualify if:

  • Male or female, age 18-62 years
  • Body mass index (BMI) 18.5-50 kg/m2
  • Subjects who are capable of giving informed consent and complying with all study procedures/requirements.
  • 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 during the study
  • Willing to use data and any accompanying charges as part of study participation
  • Willing to complete all study procedures and adhere to study visit timelines
  • Willing to be re-contacted for future research and/or follow-up

You may not qualify if:

  • Active cancer diagnosis (excluding some melanomas)
  • Have been 6-month weight unstable (gain/loss \>10 lbs in last 6 months)
  • Undergoing weight loss treatment
  • PBRC employee, as previous reviewers argued that they are not representative of the community
  • Women who are currently pregnant or breastfeeding (self-reported)
  • Diagnosed with an uncontrolled thyroid disorder (controlled = 3 months of medication)
  • Have had or plan to have weight loss surgery (gastric band removal may be allowed at PI discretion)
  • Allergic to or unwilling to eat study foods provided (exceptions made at the discretion of the PI)
  • Consume \>28 alcoholic beverages per week
  • Anyone severely immunocompromised
  • Any condition or circumstance that in the judgement of the PI could interfere with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Diktas HE, Lozano CP, Saha S, Broyles ST, Martin CK, Apolzan JW. Validity of the PortionSize and MyFitnessPal Smartphone Applications for Estimating Dietary Intake: A Randomized Crossover Clinical Trial. J Nutr. 2025 Dec;155(12):4296-4306. doi: 10.1016/j.tjnut.2025.09.027. Epub 2025 Sep 27.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Dr. Corby Martin
Organization
Pennington Biomedical Research Center

Study Officials

  • Corby K Martin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR
  • John W Apolzan, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PBRC Professor, Director - Ingestive Behavior Laboratory

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 21, 2021

Study Start

January 10, 2022

Primary Completion

November 11, 2022

Study Completion

December 31, 2025

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-11

Locations