The STEP 4Life Trial

Sponsor
University of Pennsylvania (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05069155
Collaborator
National Institute on Aging (NIA) (NIH)
100
Enrollment
1
Location
2
Arms
10.7
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Gamification
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Gamification to Improve Physical Activity in Older Adults at Risk for Alzheimer's: the STEP 4Life Trial
Actual Study Start Date :
Oct 8, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

ArmIntervention/Treatment
No Intervention: 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 intervention design.

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  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. [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 Outcome Measures

  1. Change in moderate-vigorous physical activity minutes (MVPA) during the start of the intervention period compared to baseline period. [Baseline to 12 week intervention period (Weeks 1-2)]

    We will explore changes in moderate-vigorous physical activity minutes (MVPA) during the start of the intervention period (weeks 1-2) compared to baseline period as collected by Fitbit Inspire device.

  2. Change in moderate-vigorous physical activity (MVPA) minutes during the baseline and follow-up period (weeks 13-18). [Baseline and 6 week follow-up period (Weeks 13 - 18)]

    We will explore changes in MVPA minutes in the baseline and the 6 week follow-up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Blockley HallPhiladelphiaPennsylvaniaUnited States19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Ryan Greysen, MD, MHS, MA, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05069155
Other Study ID Numbers:
  • 849329
First Posted:
Oct 6, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022