Aspire2B Personalization Pilot Study Program

January 2, 2024 updated by: PepsiCo Global R&D
This non-randomized pilot study program is focused on assessing the technical characteristics of the Aspire2B mobile device application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60661
        • Recruiting
        • Remote, no facility visits. Managed by PepsiCo R&D Life Sciences
        • Contact:
        • Sub-Investigator:
          • Shellen Goltz, PhD, RD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nutrition
Set personalized nutrition goals
Other: Nutrition
Interact with mobile app and work toward personalized nutrition goals
Other: Fitness
Set personalized fitness goals
Other: Fitness
Interact with mobile app and work toward personalized fitness goals
Other: Sleep
Set personalized sleep goals
Other: Sleep
Interact with mobile app and work toward personalized sleep goals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the technical characteristics of the app (App proficiency) -Connection
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Ability to connect wearable devices
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Face scan age
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Ability to conduct face scan to provide biological age
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Face scan stress
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Ability to conduct face scan to provide stress index
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Face scan heart rate
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Ability to conduct face scan to provide heart rate
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Onboarding
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Onboarding sequence
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Goal selection
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Ability to enter own goal
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Goal progress
Time Frame: Continuous for up to 6 weeks
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
Assess the technical characteristics of the app (App proficiency) -Points assigned
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Do points earned reflect what was completed in the app?
Continuous for up to 6 weeks
Assess the technical characteristics of the app (App proficiency) -Wellness scoring
Time Frame: Continuous for up to 6 weeks
Does the app work as intended: Does wellness score change with lifestyle changes as intended?
Continuous for up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learnings to inform future versions of the app -Retention
Time Frame: Continuous for up to 6 weeks
Exploratory analyses of the data aimed to help to inform clinical trial retention rates
Continuous for up to 6 weeks
Learnings to Inform future versions of the app -Overall engagement
Time Frame: Continuous for up to 6 weeks
Exploratory analyses of the data aimed to help to inform predictors of engagement
Continuous for up to 6 weeks
Learnings to inform changes to future versions of the app -Specific engagement
Time Frame: Continuous for up to 6 weeks
Exploratory analyses of the data aimed at informing engagement with specific app features
Continuous for up to 6 weeks
Learnings to inform changes to future versions of the app - Dietary behaviors
Time Frame: Continuous for up to 6 weeks
Exploratory analyses of the data aimed at informing improvements in self-reported diet behaviors
Continuous for up to 6 weeks
Learnings to inform changes to future versions of the app -Lifestyle behaviors
Time Frame: Continuous for up to 6 weeks
Exploratory analyses of the data aimed at informing improvements in self-reported lifestyle behaviors
Continuous for up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Tristin Brisbois, PhD, MBS, PepsiCo Global R&D

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)

March 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PEP- 2111/19 - 2302/07/08/09

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

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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