PortionSize Study 2 Free-Living Evaluation

Dietary Habits Clinical Trial

Official title:

The Reliability and Validity of the PortionSize™ and MyFitnessPal Apps (Study 2: Semi-controlled, Free-living Evaluation)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05166226
• Other study ID #: PBRC 2019-061
• Status: Active, not recruiting
• Start date: January 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 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 of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions. Participants will use PortionSize™ and MyFitnessPal apps in separate periods to test the accuracy of the respective apps.

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 has yet to be fully validated. Determining the accuracy and reliability of PortionSize™ is vital before the app can be used by people to obtain immediate feedback about their food intake. We accordingly aim to test the reliability and validity of PortionSize™ in a semi-controlled free-living environment using food provision, where participants consume pre-weighed food from a cooler and return the plate waste in the cooler. We will also test the reliability and validity of the MyFitnessPal app in the same semi-controlled free-living environment. The accuracy of the apps will also be compared to each other.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

Male or female, age 18-62 years

• Body mass index (BMI) 18.5-50 kg/m2

• Subjects who are capable of giving informed consent and complying with all study procedures/requirements.

• 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 during the study

• Willing to use data and any accompanying charges as part of study participation

• Willing to complete all study procedures and adhere to study visit timelines

• Willing to be re-contacted for future research and/or follow-up

Exclusion Criteria:

• Active cancer diagnosis (excluding some melanomas)

• Have been 6-month weight unstable (gain/loss >10 lbs in last 6 months)

• Undergoing weight loss treatment

• PBRC employee, as previous reviewers argued that they are not representative of the community

• Women who are currently pregnant or breastfeeding (self-reported)

• Diagnosed with an uncontrolled thyroid disorder (controlled = 3 months of medication)

• Have had or plan to have weight loss surgery (gastric band removal may be allowed at PI discretion)

• Allergic to or unwilling to eat study foods provided (exceptions made at the discretion of the PI)

• Consume >28 alcoholic beverages per week

• Anyone severely immunocompromised

• Any condition or circumstance that in the judgement of the PI could interfere with study participation

Related Conditions & MeSH terms

• Dietary Habits

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	Energy (kilocalorie or kcal) Intake	The primary analyses assessing equivalence between PortionSize™ and the criterion measure (and MyFitnessPal and the criterion measures) will rely on equivalence testing using the Two One-side T-test (TOST) method. The null hypothesis of an equivalence tests is that the means are nonequivalent, i.e., the confidence interval of the mean of the test condition exceeds the pre-specified error bound. The alternative hypothesis is that the means are equivalent, and the mean difference between the experimental method and gold standard is hypothesized to be zero. 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.	December 2021 through September 2022