Trial Outcomes & Findings for The STEP 4Life Trial (NCT NCT05069155)
NCT ID: NCT05069155
Last Updated: 2023-11-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Baseline to 12 week intervention period (Weeks 1 - 12)
Results posted on
2023-11-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
44
|
|
Overall Study
COMPLETED
|
49
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
Baseline characteristics by cohort
| Measure |
Control
n=50 Participants
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
n=44 Participants
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.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
34 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
70 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
10 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
24 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
2 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
2 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
42 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
92 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
1 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
1 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
44 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
92 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
0 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
44 Participants
n=7 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
94 Participants
n=5 Participants • Larger amount of participants in intervention arm dropped out or considered lost to follow-up compared to control arm.
|
|
APOE4 genotype
Carrier
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
APOE4 genotype
Non-carrier
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
APOE4 genotype
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=50 Participants
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
n=44 Participants
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.
|
|---|---|---|
|
Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period.
|
735 steps
Standard Deviation 1306
|
2422 steps
Standard Deviation 1460
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=50 Participants
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
n=44 Participants
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.
|
|---|---|---|
|
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
|
1983 steps
Standard Deviation 1478
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=50 Participants
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
n=44 Participants
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.
|
|---|---|---|
|
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
|
9.1 minutes
Standard Deviation 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=50 Participants
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
n=44 Participants
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.
|
|---|---|---|
|
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
|
8 minutes
Standard Deviation 11.9
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gamification
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=50 participants at risk
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
n=44 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.0%
2/50 • Number of events 2 • 12-week intervention and 6-week follow-up
|
4.5%
2/44 • Number of events 2 • 12-week intervention and 6-week follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place