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Completed

NCT Number: NCT05069155

The STEP 4Life Trial

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).

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Key information

Conditions

Alzheimer Disease, At Risk Alzheimer Disease Alzheimer Disease, Protection Against Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blockley Hall

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gamification

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.

Primary outcomes

  1. Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

Other outcomes

  1. Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period.

    Time frame: Baseline to 12 week intervention period (Weeks 1-2)

    MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.

  2. Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18).

    Time frame: Baseline and 6 week follow-up period (Weeks 13 - 18)

    MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 6, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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