What side effects are associated with this type of intervention?

Mobile health applications for lifestyle changes, such as those for smoking cessation, weight management, and chronic disease self-care, generally have minimal physical side effects. However, users may experience psychological effects such as frustration or anxiety if they do not achieve their goals. Additionally, there can be issues related to user engagement, such as low adherence or high dropout rates, which can impact the effectiveness of the intervention. Overall, these applications are considered safe with few adverse events reported.

What prior FDA approvals exist?

FDA approvals for lifestyle treatments often encompass digital health tools and mobile applications aimed at managing or improving health behaviors. Examples include BlueStar for diabetes management and reSET for substance use disorder. These tools are evaluated for safety, efficacy, and their potential to enhance health outcomes.

What other types of research exist?

Promising, novel alternatives to the Aspire2B mobile device application for lifestyle patients include the 'mySugr' app, which has received high usability ratings (4.1/5 for Application Quality and 4.5/5 for Application Subjective Quality) and is preferred for the self-management of Type 2 Diabetes Mellitus. Other notable applications include those identified in the usability evaluation study, which focus on T2DM and have been rated using the MARS tool for their functionality, aesthetics, and information quality.

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Fitness for Lifestyle

N/A

Recruiting

Led By Tristin Brisbois, PhD, MBS

Research Sponsored by PepsiCo Global R&D

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuous for up to 6 weeks

Awards & highlights

Study Summary

This trial is a small study that aims to evaluate the features of the Aspire2B mobile app.

Who is the study for?

This trial is for people who use smartphones and can read and understand English or Spanish. Participants must be willing to download the Aspire2B app, consent to participate in the study, and agree to the app's Terms of Use.Check my eligibility

What is being tested?

The Aspire2B Personalization Pilot Study Program is testing how well a mobile device application works in helping users with nutrition, fitness, and sleep. It's not a randomized study; participants will use the app as part of their daily routine.See study design

What are the potential side effects?

Since this trial involves using an app for lifestyle changes rather than medication, there are no traditional side effects. However, users may experience changes in behavior or lifestyle due to following guidance on nutrition, fitness, or sleep.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuous for up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuous for up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous for up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the technical characteristics of the app (App proficiency) -Connection

Assess the technical characteristics of the app (App proficiency) -Face scan age

Assess the technical characteristics of the app (App proficiency) -Face scan heart rate

+6 more

Secondary outcome measures

Learnings to Inform future versions of the app -Overall engagement

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

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

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: SleepExperimental Treatment1 Intervention

Set personalized sleep goals

Group II: NutritionExperimental Treatment1 Intervention

Set personalized nutrition goals

Group III: FitnessExperimental Treatment1 Intervention

Set personalized fitness goals

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lifestyle-related conditions, such as smoking cessation, often include behavioral interventions, pharmacotherapy, and digital health tools like mobile applications. Behavioral interventions, such as motivational interviewing and cognitive-behavioral therapy (CBT), work by changing the patient's thought patterns and behaviors related to smoking. Pharmacotherapy, including nicotine replacement therapy (NRT) and medications like varenicline, helps reduce withdrawal symptoms and cravings. Mobile health applications, like the Aspire2B app, provide real-time support, personalized feedback, and educational resources, enhancing user engagement and adherence to treatment plans. These mechanisms are crucial for lifestyle patients as they offer accessible, continuous, and tailored support, increasing the likelihood of successful behavior change and long-term health improvements.

A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial.Text Messaging to Enhance Mindfulness-Based Smoking Cessation Treatment: Program Development Through Qualitative Research.

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Who is running the clinical trial?

PepsiCo Global R&DLead Sponsor

90 Previous Clinical Trials

9,711 Total Patients Enrolled

Tristin Brisbois, PhD, MBSPrincipal InvestigatorPepsiCo Global R&D

~0 spots leftby Jun 2024

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