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Completed

NCT Number: NCT05906160

PortionSize Study 3: Assessment in Free-living Conditions

The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy intake in free-living conditions, tested against the gold-standard, doubly labeled water. Participants will use PortionSize™ and MyFitnessPal apps in separate periods to test the accuracy of the respective apps.

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Key information

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

We will recruit adults to use the PortionSize app and the MyFitnessPal free-living conditions. In a within subjects and randomized, counterbalanced design, the accuracy of the PortionSize and MyFitnessPal apps at estimating energy intake in free-living conditions will be tested against the gold-standard, doubly labeled water (DLW), over two non-consecutive four-day periods that should include at least one weekend day and encompass the same days of the week during each period. Participants will be trained in our clinic to use the apps prior to their use in free-living conditions. We will integrate customizable notifications and reminders to remotely prompt participants to record data, resolve data collection problems, etc. These notifications and reminders utilize Ecological Momentary Assessment (EMA) methodology to maximize data collection protocol adherence by reminding participants to capture and send food information at relevant times.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age 18-62 years
  • Body mass index (BMI) 18.5-50 kg/m2
  • Ownership of an iPhone model 9 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

Exclusion criteria

oHave been 6-month weight unstable (gain/loss >5% last 6 months) and/or active weight loss program

  • Any cardiometabolic disorder that significantly affects what or how much people eat
  • Active cancer diagnosis or treatment that significantly affects what or how much people eat, excluding some melanomas and other cancers
  • PBRC employee, as previous reviewers argued that they are not representative of the community (
  • 3rd member of the same household to participate (i.e. the 1st and 2nd members of the household cannot participate simultaneously)
  • 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)
  • Consume >28 alcoholic beverages per week
  • Anyone severely immunocompromised
  • Serious digestive disorders that significantly affect what or how much people eat Fluid imbalance and/or on diuretic
  • Follows a diet mainly consisting of foods that study staff deems unquantifiable for this study (i.e., liquid supplements, gluten-free specialty items) or consumes a high quantity of specialty foods
  • Any condition or circumstance that, in the judgement of the PIs, couldimpede study completion

Treatment and study plan

Primary outcomes

  1. Energy Intake (kcal)

    Time frame: May 2023 through February 2025

    Test the equivalence between PortionSize (and MyFitnessPal) and the criterion measure, which is energy intake assessed with DLW. These analyses will rely on equivalence testing using the Two One-side T-test (TOST) method, as well as Bland and Altman analyses.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

The Reliability and Validity of the PortionSize™ and MyFitnessPal Apps (Study 3: Assessment in Free-living Conditions).

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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