The STEP 4Life Trial

Gamification to Improve Physical Activity in Older Adults at Risk for Alzheimer's: the STEP 4Life Trial

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) targeting daily step counts to prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD).

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease, At Risk; Alzheimer Disease, Protection Against
• Intervention / Treatment: Behavioral: Gamification

Detailed Description

Increased physical activity by walking further or more vigorously may prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD) but reaching higher levels of activity and maintaining it as a long-term habit is difficult to do. This project will use concepts from behavioral science to create a game older adults can play in order to increase their levels of activity while having fun doing it. The game is played with a support partner who is a spouse, family member, or close friend who provides feedback and encouragement to help the game-player reach activity goals and maintain them as habits over time. Participants in the game will use their own smartphone and a wristwatch that tracks activity (such as a FitBit, provided by this study) to set goals, get feedback, and play the game for 12 weeks. Participants will be asked to continue wearing the wristwatch for another 6 weeks to track activity after the game is over. To determine the effectiveness of this game, investigators will randomly assign 50 people to the game and 50 people to only get the wristwatch but no game component. All participants in this study will be recruited from an online registry of adults age 55-75 who have not been diagnosed with Alzheimer's (GeneMatch) which offers genetic testing on risk for ADRD to all participants. Investigators will recruit participants who have elevated genetic risk as well as those without specific genetic risks for the study to see if either group responds differently to the game.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Blockley Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• own a smartphone
• be enrolled in GeneMatch
• know their genetic testing results (APOE4)
• able to provide informed consent

Exclusion Criteria:

• Inability to provide informed consent
• does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that we can provide them
• already enrolled in another physical activity study
• unable to ambulate independently
• any other medical conditions that would prohibit participation in physical activity program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Gamification; 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.	Behavioral: Gamification; Each participant signs a pre-commitment contract agreeing to try their best to achieve their daily step goal. Each week over the 12 week intervention period, participants are endowed 70 points (10/day). Participants are informed they will lose 10 points for each day the step goal is not met. Points are replenished at the start of the week. At the end of the week, if the participant has 40 points or more, he/she will advance one level, or drop one level if they have less than 40 points. The levels include: blue (lowest), bronze, silver, gold, platinum (highest). Each participant begins in the middle (silver). Each participant will also select a spouse, family member, or friend that they see often to serve as a supportive sponsor that receives a weekly email participants progress including points, game level, and average step countThis supportive sponsor will help to enhance social incentives to motivate the individual towards his or her goal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.	The primary outcome of the study is the change in mean daily steps from the baseline period to the end of the 12 week intervention period collected by Fitbit Inspire device.	Baseline to 12 week intervention period (Weeks 1 - 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The secondary outcome will examine the change in mean daily step counts during the 6 week follow-up period after the end of the 12 week intervention period.	6 week follow-up period (Weeks 13 - 18)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period.	MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.	Baseline to 12 week intervention period (Weeks 1-2)
Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18).	MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.	Baseline and 6 week follow-up period (Weeks 13 - 18)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ryan Greysen, MD, MHS, MA, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 21, 2022
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Gamification; Behavioral Science; Alzheimers Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 849329; 5P30AG012836-20 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No