Alzheimer Disease, At Risk, Alzheimer Disease, Protection Against, Dementia
Conditions
Keywords
Alzheimers Disease, Gamification, Physical activity, Behavioral Science
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.
Interventions
BEHAVIORALGamification
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.
Sponsors
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day. |
| 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) | MVPA is defined as ≥ 100 steps per minute. We will calculate minutes of MVPA per day. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
240 participants were officially consented and enrolled per study design protocol. Out of 240, 137 are deemed ineligible due to high baseline (\>7500 steps) during the 2-week run-in or did not complete all recruitment steps before the study closed for enrollment. Out of 103 randomized, 9 from the intervention arm dropped before starting the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 time in the study. | 50 |
| Gamification Intervention participants will receive a wearable device (eg. FitBit) and enter a game designed with behavioral economics concepts over a 12-week intervention period. At the end of the 12 weeks, participants will enter a 6 week follow-up period where interventions will cease but passive step data collection will continue. Participants will complete milestones within the study: cognition and function assessment at weeks 1- 2, and 15-16. They will complete an end-of-study questionnaire on their experience with the wearable device and intervention design.
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 told they will lose 10 points for each day the step goal is not met. Points are refreshed at the start of the week. At the end of the week, if the participant has 40 points or more, they 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 select a spouse, family member, or friend they see often to serve as supportive sponsor that receives a weekly email on participant progress including points, game level, and average step count. The supportive sponsor will enhance social incentives to motivate the participant towards their goal. | 44 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Control | Gamification | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 49 Participants | 42 Participants | 91 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| APOE4 genotype Carrier | 26 Participants | 26 Participants | 52 Participants |
| APOE4 genotype Missing | 1 Participants | 1 Participants | 2 Participants |
| APOE4 genotype Non-carrier | 23 Participants | 17 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 42 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 44 Participants | 92 Participants |
| Region of Enrollment United States | 50 Participants | 44 Participants | 94 Participants |
| Sex: Female, Male Female | 36 Participants | 34 Participants | 70 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 44 |
| other Total, other adverse events | 2 / 50 | 2 / 44 |
| serious Total, serious adverse events | 0 / 50 | 0 / 44 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period. | 735 steps | Standard Deviation 1306 |
| Gamification | Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period. | 2422 steps | Standard Deviation 1460 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 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 steps | Standard Deviation 1916 |
| 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. | 1983 steps | Standard Deviation 1478 |
Other Pre-specified
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period. | 4.2 minutes | Standard Deviation 6.4 |
| Gamification | Change in Moderate-vigorous Physical Activity Minutes (MVPA) During the Start of the Intervention Period Compared to Baseline Period. | 9.1 minutes | Standard Deviation 10.4 |
Other Pre-specified
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18). | 3.8 minutes | Standard Deviation 11.5 |
| Gamification | Change in Moderate-vigorous Physical Activity (MVPA) Minutes During the Baseline and Follow-up Period (Weeks 13-18). | 8 minutes | Standard Deviation 11.9 |