The STEP 4Life Trial

NCT05069155 | Completed Results

• 2 other identifiers: 8493295P30AG012836-20
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Alzheimers Disease; Gamification; Physical activity; Behavioral Science

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 week intervention period (Weeks 1 - 12)

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.

  6 week follow-up period (Weeks 13 - 18)

Other Outcomes (2)

• 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)

• 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)

Study Arms (2)

Control

NO INTERVENTION

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.

Gamification

EXPERIMENTAL

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

Interventions

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.

Gamification

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Blockley Hall

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 38962958 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Clinical research coordinator
• Organization: University of Pennsylvania

aileen.oon@pennmedicine.upenn.edu

7574471579

Study Officials

• Ryan Greysen, MD, MHS, MA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: October 6, 2021
• Study Start: November 1, 2021
• Primary Completion: November 21, 2022
• Study Completion: January 2, 2023
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)