The STEP 4Life Trial

University of Pennsylvania

Status: Completed

Conditions: Alzheimer Disease, Protection Against; Alzheimer Disease, At Risk; Dementia

Treatments: Behavioral: Gamification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05069155

5P30AG012836-20 (U.S. NIH Grant/Contract)

849329

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Gamification

Experimental group

Description:

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.

Treatment:

Behavioral: Gamification