Trial Outcomes & Findings for Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease (NCT NCT03911141)
NCT ID: NCT03911141
Last Updated: 2025-01-27
Results Overview
Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge wearable device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1062 participants
Primary outcome timeframe
Months 1-12
Results posted on
2025-01-27
Participant Flow
Before randomization, participants completed a baseline period where they wore a Fitbit for two weeks for the study team to track their average daily step counts. Week two of the baseline period was used to determine eligibility. The average of step counts over 1000 steps per day were taken to calculate the baseline step count. Participants with baseline steps over 7,500 were considered ineligible.
Participant milestones
| Measure |
Control
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
304
|
302
|
305
|
|
Overall Study
COMPLETED
|
144
|
263
|
286
|
280
|
|
Overall Study
NOT COMPLETED
|
7
|
41
|
16
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
Total
n=1062 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 8 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 8 • n=107 Participants
|
66.4 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
66.6 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 8.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
175 Participants
n=7 Participants
|
642 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
420 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
103 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
202 Participants
n=206 Participants
|
218 Participants
n=7 Participants
|
737 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
40 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
266 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian non-Hispanic
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Education
Some high school
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Education
High school graduate
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Education
Some college or specialized training
|
31 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
215 Participants
n=31 Participants
|
|
Education
College graduate
|
105 Participants
n=99 Participants
|
220 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
237 Participants
n=7 Participants
|
785 Participants
n=31 Participants
|
|
Marital Status
Single
|
27 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
159 Participants
n=31 Participants
|
|
Marital Status
Married
|
91 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
195 Participants
n=7 Participants
|
664 Participants
n=31 Participants
|
|
Marital Status
Other
|
33 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
239 Participants
n=31 Participants
|
|
Annual Household Income
Less than $50,000
|
48 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
243 Participants
n=31 Participants
|
|
Annual Household Income
$50,000 to $100,000
|
52 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
373 Participants
n=31 Participants
|
|
Annual Household Income
Greater than $100,000
|
51 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
446 Participants
n=31 Participants
|
|
Self reported health status
Excellent
|
11 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Self reported health status
Very Good
|
56 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
335 Participants
n=31 Participants
|
|
Self reported health status
Good
|
60 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
147 Participants
n=7 Participants
|
501 Participants
n=31 Participants
|
|
Self reported health status
Fair
|
23 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
152 Participants
n=31 Participants
|
|
Self reported health status
Poor
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Prior wearable device use
|
106 Participants
n=99 Participants
|
213 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
214 Participants
n=7 Participants
|
739 Participants
n=31 Participants
|
|
BMI
|
31.4 kg/m^2
STANDARD_DEVIATION 7.3 • n=99 Participants
|
31 kg/m^2
STANDARD_DEVIATION 6.3 • n=107 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 7 • n=206 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 6.5 • n=7 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 6.7 • n=31 Participants
|
|
Diabetes
|
37 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
244 Participants
n=31 Participants
|
|
Hyperlipidemia
|
77 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
155 Participants
n=7 Participants
|
565 Participants
n=31 Participants
|
|
Hypertension
|
93 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
184 Participants
n=7 Participants
|
657 Participants
n=31 Participants
|
|
Current smoking
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Prior myocardial infarction
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Stroke
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Heart Failure
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Chronic obstructive pulmonary disease
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Chronic kidney disease
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Baseline daily steps
|
4980 Average daily step counts
STANDARD_DEVIATION 1554 • n=99 Participants
|
4958 Average daily step counts
STANDARD_DEVIATION 1556 • n=107 Participants
|
5018 Average daily step counts
STANDARD_DEVIATION 1579 • n=206 Participants
|
5081 Average daily step counts
STANDARD_DEVIATION 1585 • n=7 Participants
|
5014 Average daily step counts
STANDARD_DEVIATION 1569 • n=31 Participants
|
|
Step goal selection
33% increase from baseline
|
51 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
352 Participants
n=31 Participants
|
|
Step goal selection
40% increase from baseline
|
26 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
164 Participants
n=31 Participants
|
|
Step goal selection
50% increase from baseline
|
21 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
209 Participants
n=31 Participants
|
|
Step goal selection
Custom goal
|
53 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
337 Participants
n=31 Participants
|
|
Step goal increase from baseline
|
1855 step counts
STANDARD_DEVIATION 867 • n=99 Participants
|
1890 step counts
STANDARD_DEVIATION 854 • n=107 Participants
|
1890 step counts
STANDARD_DEVIATION 829 • n=206 Participants
|
1826 step counts
STANDARD_DEVIATION 742 • n=7 Participants
|
1867 step counts
STANDARD_DEVIATION 817 • n=31 Participants
|
PRIMARY outcome
Timeframe: Months 1-12Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Change in Mean Daily Step Counts During the 12 Month Intervention Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
|
1418 Step counts
Standard Deviation 1753
|
1954 Step counts
Standard Deviation 1706
|
1915 Step counts
Standard Deviation 1903
|
2297 Step counts
Standard Deviation 1842
|
SECONDARY outcome
Timeframe: Months 1-18Change in mean daily steps from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Change in Mean Daily Step Counts During the 6 Month Follow-up Using a Wearable Pedometer (Fitbit Watch) to Measure Step Count.
|
1245 Step counts
Standard Deviation 1879
|
1708 Step counts
Standard Deviation 1882
|
1576 Step counts
Standard Deviation 2062
|
1831 Step counts
Standard Deviation 1891
|
SECONDARY outcome
Timeframe: Months 1-12Change in mean daily minutes of MVPA from baseline to the intervention period, excluding the 8-week ramp up phase. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Change in Mean Daily Minutes of Moderate to Vigorous Physical Activity (MVPA) During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
|
5.3 Minutes
Standard Deviation 9.5
|
7.4 Minutes
Standard Deviation 10.6
|
7.8 Minutes
Standard Deviation 11.1
|
9 Minutes
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Months 1-18Change in mean daily minutes of MVPA from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Change in Mean Daily Minutes of Moderate to Vigorous Physical Activity (MVPA) During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
|
4.7 Minutes
Standard Deviation 10.2
|
5.4 Minutes
Standard Deviation 11.2
|
5.3 Minutes
Standard Deviation 10.9
|
5.5 Minutes
Standard Deviation 10.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 1-12Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the intervention period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Proportion of Weeks That Achieve 150 Minutes of MVPA During the 12 Month Intervention Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
|
.16 Proportion of weeks
|
.23 Proportion of weeks
|
.24 Proportion of weeks
|
.27 Proportion of weeks
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Months 1-18Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the follow-up period. The denominator is the total number of weeks all participants in each arm participated in the study and the numerator is the number of weeks all participants had at least 150 minutes of MVPA. This will be measured using the Fitbit Charge wearable device.
Outcome measures
| Measure |
Control
n=151 Participants
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 Participants
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 Participants
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 Participants
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Proportion of Weeks That Achieve 150 Minutes of MVPA During the 6 Month Follow-up Using a Wearable Device (Fitbit Watch) to Measure MVPA Derived From Step Counts.
|
.14 Proportion of weeks
|
.18 Proportion of weeks
|
.18 Proportion of weeks
|
.20 Proportion of weeks
|
Adverse Events
Control
Serious events: 21 serious events
Other events: 80 other events
Deaths: 0 deaths
Gamification Intervention
Serious events: 51 serious events
Other events: 180 other events
Deaths: 1 deaths
Financial Incentive Intervention
Serious events: 45 serious events
Other events: 140 other events
Deaths: 0 deaths
Gamification and Financial Incentive Intervention
Serious events: 44 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=151 participants at risk
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 participants at risk
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 participants at risk
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 participants at risk
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Orthopedic
|
5.3%
8/151 • Number of events 8 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.9%
12/304 • Number of events 12 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.6%
11/302 • Number of events 12 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
4.6%
14/305 • Number of events 16 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
Cardiac disorders
Cardiovascular
|
1.3%
2/151 • Number of events 2 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.0%
9/304 • Number of events 11 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.6%
11/302 • Number of events 16 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
1.6%
5/305 • Number of events 6 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
Product Issues
Fitbit-related
|
0.00%
0/151 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
0.00%
0/304 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
0.00%
0/302 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
0.00%
0/305 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
General disorders
Other
|
7.3%
11/151 • Number of events 11 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
10.9%
33/304 • Number of events 37 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
8.6%
26/302 • Number of events 33 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
8.2%
25/305 • Number of events 33 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
Other adverse events
| Measure |
Control
n=151 participants at risk
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
|
Gamification Intervention
n=304 participants at risk
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
|
Financial Incentive Intervention
n=302 participants at risk
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Financial: Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
|
Gamification and Financial Incentive Intervention
n=305 participants at risk
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Orthopedic
|
23.2%
35/151 • Number of events 49 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
28.3%
86/304 • Number of events 106 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
18.2%
55/302 • Number of events 69 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
26.6%
81/305 • Number of events 98 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
Cardiac disorders
Cardiovascular
|
2.6%
4/151 • Number of events 4 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.0%
9/304 • Number of events 11 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
5.0%
15/302 • Number of events 21 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
3.0%
9/305 • Number of events 10 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
Product Issues
Fitbit-related
|
2.6%
4/151 • Number of events 4 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
1.3%
4/304 • Number of events 6 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
1.7%
5/302 • Number of events 6 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
2.6%
8/305 • Number of events 8 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
|
General disorders
Other
|
24.5%
37/151 • Number of events 52 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
28.0%
85/304 • Number of events 124 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
21.9%
66/302 • Number of events 92 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
23.9%
73/305 • Number of events 110 • 18 months
Adverse events were collected via participant report through study surveys at 6-months, 12-months and 18 months or participant report to study staff through text, email or phone call.
|
Additional Information
Alexander C. Fanaroff, MD, MHS
Hospital of the University of Pennsylvania
Phone: 2156157674
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place