The STEP 4Life Trial

N/A

Waitlist Available

Led By Ryan Greysen, MD, MHS, MA

Research Sponsored by University of Pennsylvania

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 baseline to 12 week intervention period (weeks 1 - 12)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a fun game can help older adults walk more to prevent Alzheimer's. Participants set daily step goals and get support from a partner. The game aims to make walking a long-term habit.

Eligible Conditions

Dementia
Memory Loss

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 week intervention period (weeks 1 - 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 week intervention period (weeks 1 - 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 week intervention period (weeks 1 - 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.

Secondary study objectives

Change in Mean Daily Step Counts During the 6 Week Follow-up Period After the End of the Intervention Period Tracked by Fitbit Inspire Device.

Other study objectives

Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18).

Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GamificationExperimental Treatment1 Intervention

Intervention participants will receive a wearable device (e.g. FitBit) and will enter a game designed with behavioral economics concepts to address predictable barriers to behavior change during a 12-week intervention period. At the end of the 12 week intervention period, participants will enter a 6 week follow-up period during which interventions will cease but passive data collection of step counts will continue. Participants will also complete milestones within the study, such as the cognition and function assessment during weeks 1- 2, and 15-16. Participants will complete an end-of-study questionnaire on their experience with the wearable device and intervention design.

Group II: ControlActive Control1 Intervention

Participants will receive a wearable device (e.g. FitBit) but no other interventions during the intervention or follow-up periods.Participants will also complete milestones within the study, such as the cognition and function assessment during weeks 1- 2, and 15-16. Participants will complete an end-of-study questionnaire on their experience with the wearable device and time in the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gamification

2019

Completed Phase 3

~3090

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