Aspire2B Personalization Pilot Study Program
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Shellen Goltz, PhD, RD
- Phone Number: 312-821-3317
- Email: Shellen.Goltz@pepsico.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60661
- Remote, no facility visits. Managed by PepsiCo R&D Life Sciences
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Nutrition
Set personalized nutrition goals
|
Interact with mobile app and work toward personalized nutrition goals
|
|
Other: Fitness
Set personalized fitness goals
|
Interact with mobile app and work toward personalized fitness goals
|
|
Other: Sleep
Set personalized sleep goals
|
Interact with mobile app and work toward personalized sleep goals
|
What is the study measuring?
Primary Outcome Measures
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?
An improved wellness score is better.
|
Continuous for up to 6 weeks
|
Secondary Outcome Measures
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Tristin Brisbois, PhD, MBS, PepsiCo Global R&D
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PEP- 2111/19 - 2302/07/08/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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