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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04494971
Other study ID # PBRC 2019-013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 31, 2020
Est. completion date November 20, 2020

Study information

Verified date May 2024
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of portion size at estimating energy intake Compared measurements from PortionSize to weighed values in the lab. August - December 2020
Primary Reliability of portion size at estimating energy intake Quantify the reliability of app measurements over time in free-living conditions. August - December 2020
Secondary User satisfaction Participant ratings of the PortionSize App August - December 2020
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