An interventional study of Gamification in Alzheimer Disease, At Risk, Alzheimer Disease, Protection Against and Dementia, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
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).
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 240 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
Time frame: Baseline to 12 week intervention period (Weeks 1 - 12)
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.
Time frame: 6 week follow-up period (Weeks 13 - 18)
Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period.
MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.
Time frame: 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).
MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.
Time frame: Baseline and 6 week follow-up period (Weeks 13 - 18)
After a participant consented to participating in the study, they are given a Fitbit device to wear for a 2 week run-in period to collect step and sleep data to estimate their 2-week baseline. Participants with a baseline above 7500 are excluded from the study due to them being too active.
| Milestone | Control | Gamification |
|---|---|---|
| Started | 50 | 44 |
| Completed | 49 | 41 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 3 |
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.
| steps | Control | Gamification |
|---|---|---|
| Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period. | 735 ± 1306 | 2422 ± 1460 |
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.
| steps | Control | Gamification |
|---|---|---|
| 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. | 705 ± 1916 | 1983 ± 1478 |
MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.
| minutes | Control | Gamification |
|---|---|---|
| Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period. | 4.2 ± 6.4 | 9.1 ± 10.4 |
MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day.
| minutes | Control | Gamification |
|---|---|---|
| Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18). | 3.8 ± 11.5 | 8 ± 11.9 |
Collected over 12-week intervention and 6-week follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/50 (0%) | 0/50 (0%) | 2/50 (4%) |
| Gamification | 0/44 (0%) | 0/44 (0%) | 2/44 (4.5%) |
| Event | Control | Gamification |
|---|---|---|
| Skin rashSkin and subcutaneous tissue disorders | 2/50 | 2/44 |
94 participants were started in the study, but 4 participants dropped out. 90 participants completed the entire study.
| Age, Categorical(Participants) | Control | Gamification | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 49 | 42 | 91 |
| Sex: Female, Male(Participants) | Control | Gamification | Total |
|---|---|---|---|
| Female | 36 | 34 | 70 |
| Male | 14 | 10 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Control | Gamification | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 50 | 42 | 92 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Gamification | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 48 | 44 | 92 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Control | Gamification | Total |
|---|---|---|---|
| United States | 50 | 44 | 94 |
| APOE4 genotype(Participants) | Control | Gamification | Total |
|---|---|---|---|
| Carrier | 26 | 26 | 52 |
| Non-carrier | 23 | 17 | 40 |
| Missing | 1 | 1 | 2 |
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Plan to share: No — Individual participant data will not be made available.
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