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The STEP 4Life Trial

Primary Purpose

Alzheimer Disease, At Risk, Alzheimer Disease, Protection Against, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamification
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease, At Risk focused on measuring Alzheimers Disease, Gamification, Physical activity, Behavioral Science

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Blockley Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Gamification

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in mean daily steps from the baseline period to the end of the 12 week intervention period.
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

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.
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.

Full Information

First Posted
July 8, 2021
Last Updated
January 4, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05069155
Brief Title
The STEP 4Life Trial
Official Title
Gamification to Improve Physical Activity in Older Adults at Risk for Alzheimer's: the STEP 4Life Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, At Risk, Alzheimer Disease, Protection Against, Dementia
Keywords
Alzheimers Disease, Gamification, Physical activity, Behavioral Science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Gamification
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Gamification
Intervention Description
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 Outcome Measure Information:
Title
Change in mean daily steps from the baseline period to the end of the 12 week intervention period.
Description
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.
Time Frame
Baseline to 12 week intervention period (Weeks 1 - 12)
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 week follow-up period (Weeks 13 - 18)
Other Pre-specified Outcome Measures:
Title
Change in moderate-vigorous physical activity minutes (MVPA) during the start of the intervention period compared to baseline period.
Description
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.
Time Frame
Baseline to 12 week intervention period (Weeks 1-2)
Title
Change in moderate-vigorous physical activity (MVPA) minutes during the baseline and follow-up period (weeks 13-18).
Description
We will explore changes in MVPA minutes in the baseline and the 6 week follow-up period.
Time Frame
Baseline and 6 week follow-up period (Weeks 13 - 18)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Greysen, MD, MHS, MA
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blockley Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available.

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The STEP 4Life Trial

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