Dietary HabitsNCT04700904
PortionSize Study 1 Laboratory-based Evaluation)
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 and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 31 Dec 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy participants ages 18 to 70 in the Baton Rouge, LA area.
Who may be able to join
- 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
Who cannot join
- Center employee
- Any condition or circumstance that could impede study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research
Baton Rouge, Louisiana, 70808
About this study
Official title: The Reliability and Validity of the PortionSize and MyFitnessPal Apps (Study 1: Laboratory-based Evaluation)
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.
- 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.
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.
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start10 Feb 2021
- Primary completion6 Oct 2021
- Study completion31 Dec 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 43 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, PhD, Principal investigator, Pennington Biomedical Research CenterCorby K Martin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700904
- Sponsor's protocol ID
- PBRC 2019-062
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2021
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lozano CP, Neubig KE, Saha S, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize application compared with that of MyFitnessPal for accurately estimating intake: a randomized crossover laboratory-based evaluation. Am J Clin Nutr. 2024 Aug;120(2):419-430. doi: 10.1016/j.ajcnut.2024.05.023. Epub 2024 May 31.
PubMed 38825184
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. 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 1: Laboratory-based Evaluation)
- ClinicalTrials.gov ID
- NCT04700904
- Acronym / sponsor ID
- PBRC 2019-062
- Conditions
- Dietary Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Posted 27 Jan 2025
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 and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals.
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
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants ages 18 to 70 in the Baton Rouge, LA area.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Center employee
- Any condition or circumstance that could impede study completion
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
Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).
Time frame: 2.5 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38825184Lozano CP, Neubig KE, Saha S, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize application compared with that of MyFitnessPal for accurately estimating intake: a randomized crossover laboratory-based evaluation. Am J Clin Nutr. 2024 Aug;120(2):419-430. doi: 10.1016/j.ajcnut.2024.05.023. Epub 2024 May 31.
- 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, PhD principal investigator
Pennington Biomedical Research Center
Corby K Martin, PhD 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 6 inclusion and 2 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 27 Jan 2025. 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 27 Jan 2025). 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?
Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal). (time frame: 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700904, which also lists 1 linked publication.
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 27 Jan 2025.