Aspire2B Personalization Pilot Study Program

Behavior Clinical Trial

Official title:

Aspire2B Personalization Pilot Study Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191822
• Other study ID #: PEP- 2111/19 - 2302/07/08/09
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: PepsiCo Global R&D
• Contact: Shellen Goltz, PhD, RD
• Phone: 312-821-3317
• Email: Shellen.Goltz[@]pepsico.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This non-randomized pilot study program is focused on assessing the technical characteristics of the Aspire2B mobile device application.

Description:

Aspire2B is a mobile wellness app that uses non-invasive measurements to predict various physiological states and estimate biological age. Users are then enrolled in nutrition, fitness, or sleep challenges within the app that are aimed at improving overall wellness and thus helping to reduce biological age. Mobile health (mHealth) interventions require numerous decisions that integrate behavioral theory, user feedback, and technical and practical feasibility considerations. The main purpose of this research program is to test if the application works as intended. This pilot study program is managed internally by Pepsico clinical researchers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Fluent in reading and understanding English or Spanish
• Smartphone users

Exclusion Criteria:

• Cannot proceed to onboarding without downloading the app, consenting to participate, and agreeing to app Terms of Use

Related Conditions & MeSH terms

• Behavior
• Lifestyle

Intervention

Other:
• Nutrition
Interact with mobile app and work toward personalized nutrition goals
• Fitness
Interact with mobile app and work toward personalized fitness goals
• Sleep
Interact with mobile app and work toward personalized sleep goals

Locations

Country	Name	City	State
United States	Remote, no facility visits. Managed by PepsiCo R&D Life Sciences	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the technical characteristics of the app (App proficiency) -Connection	Does the app work as intended: Ability to connect wearable devices	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Face scan age	Does the app work as intended: Ability to conduct face scan to provide biological age	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Face scan stress	Does the app work as intended: Ability to conduct face scan to provide stress index	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Face scan heart rate	Does the app work as intended: Ability to conduct face scan to provide heart rate	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Onboarding	Does the app work as intended: Onboarding sequence	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Goal selection	Does the app work as intended: Ability to enter own goal	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Goal progress	Does the app work as intended: Ability to track and measure goal progress (e.g., steps from a wearable device)	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Points assigned	Does the app work as intended: Do points earned reflect what was completed in the app?	Continuous for up to 6 weeks
Primary	Assess the technical characteristics of the app (App proficiency) -Wellness scoring	Does the app work as intended: Does wellness score change with lifestyle changes as intended?	Continuous for up to 6 weeks
Secondary	Learnings to inform future versions of the app -Retention	Exploratory analyses of the data aimed to help to inform clinical trial retention rates	Continuous for up to 6 weeks
Secondary	Learnings to Inform future versions of the app -Overall engagement	Exploratory analyses of the data aimed to help to inform predictors of engagement	Continuous for up to 6 weeks
Secondary	Learnings to inform changes to future versions of the app -Specific engagement	Exploratory analyses of the data aimed at informing engagement with specific app features	Continuous for up to 6 weeks
Secondary	Learnings to inform changes to future versions of the app - Dietary behaviors	Exploratory analyses of the data aimed at informing improvements in self-reported diet behaviors	Continuous for up to 6 weeks
Secondary	Learnings to inform changes to future versions of the app -Lifestyle behaviors	Exploratory analyses of the data aimed at informing improvements in self-reported lifestyle behaviors	Continuous for up to 6 weeks