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PortionSize Study 1 Laboratory-based Evaluation)

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04700904
Collaborator
(none)
43
Enrollment
1
Location
17.6
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Reliability and Validity of the PortionSize and MyFitnessPal Apps (Study 1: Laboratory-based Evaluation)
    Actual Study Start Date :
    Feb 10, 2021
    Actual Primary Completion Date :
    Oct 6, 2021
    Anticipated Study Completion Date :
    Jul 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Energy Intake [February - December 2021]

      The primary analyses assessing equivalence between PortionSize and the criterion measures (and MyFitnessPal and the criterion measures), will rely on equivalence testing using the Two One-side T-test (TOST) method. The criterion measure is directly weighed foods from the simulated lunch meal. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    • Center employee

    • Any condition or circumstance that could impede study completion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center

    Investigators

    • Principal Investigator: John W Apolzan, PhD, Pennington Biomedical Research Center
    • Principal Investigator: James J Dorling, PhD, Pennington Biomedical Research Center
    • Principal Investigator: Stephanie J Broyles, PhD, Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Corby K. Martin, PBRC Professor, Director - Ingestive Behavior Laboratory, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT04700904
    Other Study ID Numbers:
    • PBRC_2019_062
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 28, 2022