The STEP 4Life Trial

Not Applicable

Completed

• Conditions: Alzheimer Disease, Protection Against; Alzheimer Disease, At Risk; Dementia
• Interventions: Behavioral: Gamification

• Registration Number: NCT05069155
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Study Start: 2021-11-01
• Primary Completion: 2022-11-21
• Study Completion: 2023-01-02
• Results First Submitted: 2023-07-06
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamification	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.

Primary Outcome Measures

Name	Time	Method
Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.	Baseline to 12 week intervention period (Weeks 1 - 12)	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.

Secondary Outcome Measures

Name	Time	Method
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.	6 week follow-up period (Weeks 13 - 18)	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.

Trial Locations

Locations (1)

Blockley Hall; 🇺🇸 Philadelphia, Pennsylvania, United States