NCT06191822

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

September 13, 2023

Last Update Submit

January 2, 2024

Conditions

App ProficiencyBehaviorLifestyle

Keywords

Biological ageWellness app

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • Assess the technical characteristics of the app (App proficiency) -Onboarding

    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

    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

    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

    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

    Does the app work as intended: Does wellness score change with lifestyle changes as intended?

    Continuous for up to 6 weeks

Secondary Outcomes (5)

  • Learnings to inform future versions of the app -Retention

    Continuous for up to 6 weeks

  • Learnings to Inform future versions of the app -Overall engagement

    Continuous for up to 6 weeks

  • Learnings to inform changes to future versions of the app -Specific engagement

    Continuous for up to 6 weeks

  • Learnings to inform changes to future versions of the app - Dietary behaviors

    Continuous for up to 6 weeks

  • Learnings to inform changes to future versions of the app -Lifestyle behaviors

    Continuous for up to 6 weeks

Study Arms (3)

Nutrition

OTHER

Set personalized nutrition goals

Other: Nutrition

Fitness

OTHER

Set personalized fitness goals

Other: Fitness

Sleep

OTHER

Set personalized sleep goals

Other: Sleep

Interventions

NutritionOTHER

Interact with mobile app and work toward personalized nutrition goals

Nutrition
FitnessOTHER

Interact with mobile app and work toward personalized fitness goals

Fitness
SleepOTHER

Interact with mobile app and work toward personalized sleep goals

Sleep

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remote, no facility visits. Managed by PepsiCo R&D Life Sciences

Chicago, Illinois, 60661, United States

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Nutritional StatusSleep

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tristin Brisbois, PhD, MBS

    PepsiCo Global R&D

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shellen Goltz, PhD, RD

CONTACT

312-821-3317Shellen.Goltz@pepsico.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

January 5, 2024

Study Start

March 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)