Clinical trial NCT05069155: The STEP 4Life Trial
Official title: Gamification to Improve Physical Activity in Older Adults at Risk for Alzheimer's: the STEP 4Life Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease, At Risk
Alzheimer Disease, Protection Against
Dementia
Keywords: Alzheimers Disease
Gamification
Physical activity
Behavioral Science
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-10-06
Enrollment: 240
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2-arm, randomized, controlled trial over 12 weeks with 6 weeks of follow-up (18 weeks total) that compares a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.
timeFrame: Baseline to 12 week intervention period (Weeks 1 - 12)
Secondary outcomes:
measure: 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.
timeFrame: 6 week follow-up period (Weeks 13 - 18)
Other outcomes:
measure: Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period.
timeFrame: Baseline to 12 week intervention period (Weeks 1-2)
measure: Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18).
timeFrame: Baseline and 6 week follow-up period (Weeks 13 - 18)
Locations:
city: Philadelphia
country: United States
facility: Blockley Hall
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ryan Greysen, MD, MHS, MA
role: PRINCIPAL_INVESTIGATOR
References: