Dietary HabitsNCT05906160
PortionSize Study 3: Assessment in Free-living Conditions
An observational study of Dietary Habits, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Dietary Habits
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Adult
Study population: Adults aged 18-62, males and females.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Reliability and Validity of the PortionSize™ and MyFitnessPal Apps (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.
Read the detailed description
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.
- Conditions
- Dietary Habits
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy (Kilocalorie or kcal) Intake
Mean difference in measured energy intake between PortionSize (and MyFitnessPal) and the criterion measure (DLW). These analyses 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.
Mean differences were calculated as mean daily energy intake estimated from DLW subtracted from the mean energy intake measured by each of the tested apps. Therefore, negative values indicate an underestimation while positive values indicate an overestimation.
Measured: 4 days for each app (PortionSize and MyFitnessPal) and an overlapping 12 days for DLW
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start22 Jun 2023
- Primary completion25 Nov 2024
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
- Investigators
- John W Apolzan, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906160
- Sponsor's protocol ID
- PBRC 2019-063
- Status last verified
- Jul 2026
- First submitted
- 26 May 2023
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the PortionSize™ and MyFitnessPal Apps (Study 3: Assessment in Free-living Conditions).
- ClinicalTrials.gov ID
- NCT05906160
- Acronym / sponsor ID
- PBRC 2019-063
- Conditions
- Dietary Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 19 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adults aged 18-62, males and females.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy (Kilocalorie or kcal) Intake
Time frame: 4 days for each app (PortionSize and MyFitnessPal) and an overlapping 12 days for DLW
Mean difference in measured energy intake between PortionSize (and MyFitnessPal) and the criterion measure (DLW). These analyses 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. Mean differences were calculated as mean daily energy intake estimated from DLW subtracted from the mean energy intake measured by each of the tested apps. Therefore, negative values indicate an underestimation while positive values indicate an overestimation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Apolzan, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy (Kilocalorie or kcal) Intake (time frame: 4 days for each app (PortionSize and MyFitnessPal) and an overlapping 12 days for DLW). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.