The STEP 4Life Trial

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069155
• Other study ID #: 849329
• Secondary ID: 5P30AG012836-20
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2, 2023

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2, 2023
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Protection Against
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Blockley Hall	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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)