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The STEP 4Life Trial

NCT ID: NCT05069155

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-01-02

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease, At Risk Alzheimer Disease, Protection Against Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Gamification

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Greysen, MD, MHS, MA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Blockley Hall

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Greysen SR, Oon AL, Harkins K, Rareshide C, Mondal A, Patel MS, Grill JD, Karlawish J. Effect of gamification with a support partner to increase physical activity in older adults at risk for Alzheimer's disease: The STEP 4Life randomized clinical trial. Alzheimers Dement. 2024 Aug;20(8):5450-5459. doi: 10.1002/alz.14058. Epub 2024 Jul 4.

Reference Type DERIVED
PMID: 38962958 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P30AG012836-20

Identifier Type: NIH

Identifier Source: secondary_id

View Link

849329

Identifier Type: -

Identifier Source: org_study_id