Dietary HabitsPS PilotNCT04494971
The PortionSize Smartphone App Pilot (PS Pilot)
An observational study of Dietary Habits, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dietary Habits
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 20 Nov 2020
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Healthy participants ages 18 to 65 in the Baton Rouge, LA area.
Who may be able to join
- BMI 18.5-45 kg/m2 based upon self-reported height and weight
- Have an iPhone and an operable Apple ID, password, and email address and is willing to use these to collect data during the study, acknowledging that data usage, and associated charges, are a result of study participation
Who cannot join
- For females, pregnancy or breast feeding
- Currently diagnosed with an eating disorder
- Disease that severely affects metabolism, including diabetes, hypercholesterolemia, or dyslipidemia
- Has gained or lost more than 10 lbs in the last 3 months
- PBRC faculty/staff member
- Has suffered serious mental illness that has resulted in serious functional impairment and has substantially interfered with one's life activities within the last 5 years
- Any other medical, psychiatric, or behavioral factors in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol
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: Pilot Validation of an App to Estimate and Manage Portion Size: The PortionSize Smartphone App
The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.
Read the detailed description
Overweight and obesity are a burgeoning public health concern, yet only a small minority of smartphone apps that claim to facilitate healthy eating and weight loss incorporate evidence-based principles. Such innovations are important as humans fundamentally cannot accurately estimate portion size. Indeed, portion size estimation errors account for ~50% of the error in self-reported food intake, and data from our laboratory has demonstrated that extensive training results in only modest improvements in portion size estimation accuracy and that portion size estimates remain inaccurate. Our long-term goal is to create simple and accessible interventions that assist individuals with weight control. In particular, we aim to provide easy-to-use phone apps that allow participants to monitor the portion sizes of the foods they consume. These apps guide participants on appropriate portion sizes and provide recommendations of food groups that should be consumed. To that end, we have developed the PortionSize app. We propose to improve the accuracy of portion size measurement, as it is poorly determined by self-report measures. This will occur via the development of the PortionSize smartphone app and this pilot study will test the usability as well as preliminary validity and reliability of the app functionality.
- 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.
Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions
Compared measurements from PortionSize to weighed values in the laboratory, which is the criterion measure.
Measured: 1 simulated meal collected on one day
Validity of Portion Size at Estimating Energy Intake in Free-living Conditions
Quantify the validity of the app measurements in free-living conditions compared to digital photography (the criterion measure).
Measured: Mean kcal intake over 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start31 Aug 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
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 only
- Time perspective
- Prospective
- Enrolment
- 15 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 Apolzan, PhD, Principal investigator, Pennington Biomedical Research CenterJames Dorling, PhD, Principal investigator, Pennington Biomedical Research CenterCorby Martin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494971
- Sponsor's protocol ID
- PBRC 2019-013
- Acronym
- PS Pilot
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2020
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diktas HE, Lozano CP, Saha S, Broyles ST, Martin CK, Apolzan JW. Evaluating the Validity of the PortionSize Smartphone Application for Estimating Dietary Intake in Free-Living Conditions: A Pilot Study. J Nutr Educ Behav. 2024 Sep;56(9):643-652. doi: 10.1016/j.jneb.2024.05.226. Epub 2024 Jun 18.
PubMed 38888538
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Validation of an App to Estimate and Manage Portion Size: The PortionSize Smartphone App
- ClinicalTrials.gov ID
- NCT04494971
- Acronym / sponsor ID
- PS Pilot / PBRC 2019-013
- Conditions
- Dietary Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 15 Oct 2024
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 examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.
Detailed description
Overweight and obesity are a burgeoning public health concern, yet only a small minority of smartphone apps that claim to facilitate healthy eating and weight loss incorporate evidence-based principles. Such innovations are important as humans fundamentally cannot accurately estimate portion size. Indeed, portion size estimation errors account for ~50% of the error in self-reported food intake, and data from our laboratory has demonstrated that extensive training results in only modest improvements in portion size estimation accuracy and that portion size estimates remain inaccurate. Our long-term goal is to create simple and accessible interventions that assist individuals with weight control. In particular, we aim to provide easy-to-use phone apps that allow participants to monitor the portion sizes of the foods they consume. These apps guide participants on appropriate portion sizes and provide recommendations of food groups that should be consumed. To that end, we have developed the PortionSize app. We propose to improve the accuracy of portion size measurement, as it is poorly determined by self-report measures. This will occur via the development of the PortionSize smartphone app and this pilot study will test the usability as well as preliminary validity and reliability of the app functionality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy participants ages 18 to 65 in the Baton Rouge, LA area.
Key inclusion criteria (2 listed)
- BMI 18.5-45 kg/m2 based upon self-reported height and weight
- Have an iPhone and an operable Apple ID, password, and email address and is willing to use these to collect data during the study, acknowledging that data usage, and associated charges, are a result of study participation
Key exclusion criteria (7 listed)
- For females, pregnancy or breast feeding
- Currently diagnosed with an eating disorder
- Disease that severely affects metabolism, including diabetes, hypercholesterolemia, or dyslipidemia
- Has gained or lost more than 10 lbs in the last 3 months
- PBRC faculty/staff member
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
Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions
Time frame: 1 simulated meal collected on one day
Compared measurements from PortionSize to weighed values in the laboratory, which is the criterion measure.
Validity of Portion Size at Estimating Energy Intake in Free-living Conditions
Time frame: Mean kcal intake over 3 days
Quantify the validity of the app measurements in free-living conditions compared to digital photography (the criterion measure).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38888538Diktas HE, Lozano CP, Saha S, Broyles ST, Martin CK, Apolzan JW. Evaluating the Validity of the PortionSize Smartphone Application for Estimating Dietary Intake in Free-Living Conditions: A Pilot Study. J Nutr Educ Behav. 2024 Sep;56(9):643-652. doi: 10.1016/j.jneb.2024.05.226. Epub 2024 Jun 18.
- Individual participant dataSharing planned: No
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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 Apolzan, PhD principal investigator
Pennington Biomedical Research Center
James Dorling, PhD principal investigator
Pennington Biomedical Research Center
Corby 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 2 inclusion and 7 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 Nov 2024. 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 15 Oct 2024). 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?
Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions (time frame: 1 simulated meal collected on one day). The study lists 2 primary outcomes in all. 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 NCT04494971, 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 19 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.