Trial Outcomes & Findings for Way to Be Active I (Teams) (NCT NCT02001194)
NCT ID: NCT02001194
Last Updated: 2019-03-05
Results Overview
Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes for 3 months (13 weeks) with the interventions and 3 months (13 weeks) without intervention during the follow-up period. We will use all available data and treat missing as true missing data points. Secondary outcomes will include the average steps walked per day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
End of study- 6 months of after enrollment
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Control
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
|
Individual
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.
Individual Incentives
|
Team
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.
Team Incentives
|
Individual Plus Team
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.
Individual plus Team Incentives
|
|---|---|---|---|---|
|
Intervention Period (13 Weeks)
STARTED
|
68
|
80
|
76
|
80
|
|
Intervention Period (13 Weeks)
COMPLETED
|
67
|
80
|
74
|
78
|
|
Intervention Period (13 Weeks)
NOT COMPLETED
|
1
|
0
|
2
|
2
|
|
Follow-Up Period (13 Weeks)
STARTED
|
67
|
80
|
74
|
78
|
|
Follow-Up Period (13 Weeks)
COMPLETED
|
64
|
78
|
73
|
78
|
|
Follow-Up Period (13 Weeks)
NOT COMPLETED
|
3
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
|
Individual
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.
Individual Incentives
|
Team
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.
Team Incentives
|
Individual Plus Team
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.
Individual plus Team Incentives
|
|---|---|---|---|---|
|
Intervention Period (13 Weeks)
No longer interested
|
1
|
0
|
2
|
2
|
|
Follow-Up Period (13 Weeks)
No longer interested
|
3
|
2
|
1
|
0
|
Baseline Characteristics
Way to Be Active I (Teams)
Baseline characteristics by cohort
| Measure |
Control
n=68 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
|
Individual
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.
Individual Incentives
|
Team
n=76 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.
Team Incentives
|
Individual Plus Team
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.
Individual plus Team Incentives
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Marital Status
Single
|
28 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Marital Status
Married
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Marital Status
Other
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Education
Less than college
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Education
Some college
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Education
College graduate
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Education
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Annual Household Income
Less than $50,000
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Annual Household Income
$50,000 to $100,000
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Annual Household Income
Greater than $100,000
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Annual Household Income
Unknown
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
iPhone smartphone
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Race/Ethnicity
White non-Hispanic
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Race/Ethnicity
African American non-Hispanic
|
22 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race/Ethnicity
Other non-Hispanic
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity
Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: End of study- 6 months of after enrollmentOur primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes for 3 months (13 weeks) with the interventions and 3 months (13 weeks) without intervention during the follow-up period. We will use all available data and treat missing as true missing data points. Secondary outcomes will include the average steps walked per day.
Outcome measures
| Measure |
Control
n=68 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
|
Individual
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.
Individual Incentives
|
Team
n=76 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.
Team Incentives
|
Individual Plus Team
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.
Individual plus Team Incentives
|
|---|---|---|---|---|
|
Proportion of Days a Minimum Activity of 7000 Steps or More is Achieved
Intervention Period
|
0.176 Proportion of participant-days
Interval 0.101 to 0.25
|
0.254 Proportion of participant-days
Interval 0.185 to 0.322
|
0.173 Proportion of participant-days
Interval 0.103 to 0.243
|
0.350 Proportion of participant-days
Interval 0.281 to 0.419
|
|
Proportion of Days a Minimum Activity of 7000 Steps or More is Achieved
Follow Up Period
|
0.142 Proportion of participant-days
Interval 0.068 to 0.215
|
0.187 Proportion of participant-days
Interval 0.12 to 0.255
|
0.152 Proportion of participant-days
Interval 0.082 to 0.221
|
0.235 Proportion of participant-days
Interval 0.167 to 0.302
|
SECONDARY outcome
Timeframe: End of study- 6 months after enrollmentSecondary outcomes include average number of steps per day during intervention period and the follow-up period.
Outcome measures
| Measure |
Control
n=68 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive.
|
Individual
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day.
Individual Incentives
|
Team
n=76 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day.
Team Incentives
|
Individual Plus Team
n=80 Participants
Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal.
Individual plus Team Incentives
|
|---|---|---|---|---|
|
Average Number of Steps Per Day During Intervention
Intervention Period (3 months with incentives)
|
3929.1 steps per day
Interval 3170.5 to 4687.7
|
4516.4 steps per day
Interval 3817.1 to 5215.8
|
3929.6 steps per day
Interval 3212.1 to 4647.4
|
5280.3 steps per day
Interval 4580.9 to 5979.7
|
|
Average Number of Steps Per Day During Intervention
Follow Up Period (3 months without incentives)
|
3619.1 steps per day
Interval 2827.3 to 4410.8
|
3957.8 steps per day
Interval 3227.8 to 4687.7
|
3713.1 steps per day
Interval 2964.1 to 4462.0
|
4616.0 steps per day
Interval 3886.1 to 5346.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Team
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Plus Team
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place