- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494971
The PortionSize Smartphone App Pilot (PS Pilot) (PS Pilot)
October 31, 2024 updated by: Corby K. Martin, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Healthy participants ages 18 to 65 in the Baton Rouge, LA area.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 simulated meal collected on one day
|
|
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).
|
Mean kcal intake over 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User satisfaction
Time Frame: August - December 2020
|
Participant ratings of the PortionSize App
|
August - December 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Apolzan, PhD, Pennington Biomedical Research Center
- Principal Investigator: James Dorling, PhD, Pennington Biomedical Research Center
- Principal Investigator: Corby Martin, PhD, Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2020
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
November 20, 2020
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Estimated)
November 19, 2024
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 2019-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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