PortionSize Study 1 Laboratory-based Evaluation)

Dietary Habits Clinical Trial

Official title:

The Reliability and Validity of the PortionSize and MyFitnessPal Apps (Study 1: Laboratory-based Evaluation)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04700904
• Other study ID #: PBRC 2019-062
• Status: Active, not recruiting
• Start date: February 10, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 31, 2024
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Center employee

• Any condition or circumstance that could impede study completion

Related Conditions & MeSH terms

• Dietary Habits

Locations

Country	Name	City	State
United States	Pennington Biomedical Research	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	Energy Intake	The primary analyses assessing equivalence between PortionSize and the criterion measures (and MyFitnessPal and the criterion measures), will rely on equivalence testing using the Two One-side T-test (TOST) method. The criterion measure is directly weighed foods from the simulated lunch meal. Differences in error from PortionSize compared to error from MyFitnessPal will be assessed using dependent samples t-tests, with error calculated as the difference between each experimental method and the criterion variable (e.g., energy intake values from PortionSize minus energy intake values from weighed foods). These procedures will also produce results indicating if the error from each method differs from zero.	February - December 2021