Trial Outcomes & Findings for Way to Be Active III (Framing Incentives) (NCT NCT02030119)
NCT ID: NCT02030119
Last Updated: 2017-12-02
Results Overview
The primary outcome measure is the mean proportion of participant-days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
281 participants
Primary outcome timeframe
Throughout the 6 month study
Results posted on
2017-12-02
Participant Flow
One participant randomly assigned to the gain-incentive group was later found to be ineligible due to previous enrollment in another physical activity study. One participant randomly assigned to the lottery-incentive group switched to a phone that was not eligible for use before the study began and therefore did not receive the intervention.
Participant milestones
| Measure |
Control
The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.
Daily feedback
|
Gain Framing
Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.
Financial Incentives
Daily feedback
|
Daily Lottery
Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.
Financial Incentives
Daily feedback
|
Loss Framing
The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.
Financial Incentives
Daily feedback
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
71
|
70
|
|
Overall Study
COMPLETED
|
67
|
68
|
65
|
67
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
6
|
3
|
Reasons for withdrawal
| Measure |
Control
The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.
Daily feedback
|
Gain Framing
Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.
Financial Incentives
Daily feedback
|
Daily Lottery
Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.
Financial Incentives
Daily feedback
|
Loss Framing
The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.
Financial Incentives
Daily feedback
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
5
|
3
|
|
Overall Study
Ineligible (see Pre-assignment Details)
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Analysis population (n=279)
Baseline characteristics by cohort
| Measure |
Control
n=70 Participants
The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.
Daily feedback
|
Gain Framing
n=69 Participants
Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.
Financial Incentives
Daily feedback
|
Daily Lottery
n=70 Participants
Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.
Financial Incentives
Daily feedback
|
Loss Framing
n=70 Participants
The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.
Financial Incentives
Daily feedback
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.4 years of age
STANDARD_DEVIATION 12.2 • n=5 Participants
|
37.1 years of age
STANDARD_DEVIATION 10.9 • n=7 Participants
|
40.3 years of age
STANDARD_DEVIATION 11.2 • n=5 Participants
|
41.9 years of age
STANDARD_DEVIATION 11.6 • n=4 Participants
|
39.7 years of age
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Mean BMI
|
33.2 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=7 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
33.8 kg/m^2
STANDARD_DEVIATION 6.8 • n=4 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Median physical activity in the past 7 d, MET-min
|
2568.8 Metabolic equivalent minutes (MET-min)
n=5 Participants • Analysis population (n=279)
|
2812.2 Metabolic equivalent minutes (MET-min)
n=7 Participants • Analysis population (n=279)
|
2785.0 Metabolic equivalent minutes (MET-min)
n=5 Participants • Analysis population (n=279)
|
2764.5 Metabolic equivalent minutes (MET-min)
n=4 Participants • Analysis population (n=279)
|
2709.3 Metabolic equivalent minutes (MET-min)
n=21 Participants • Analysis population (n=279)
|
|
Race/ethnicity
White non-Hispanic
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Race/ethnicity
African American non-Hispanic
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/ethnicity
Other non-Hispanic
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/ethnicity
Hispanic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Education
Less than college
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Education
Some college
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Education
College graduate
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
|
Marital status
Single
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Marital status
Married
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Marital status
Other
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Annual household income
<$50,000
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Annual household income
$50,000-$100,000
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Annual household income
>$100,000
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Number of Participants with iPhone smartphone
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Throughout the 6 month studyThe primary outcome measure is the mean proportion of participant-days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives.
Outcome measures
| Measure |
Control
n=70 Participants
The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.
Daily feedback
|
Gain Framing
n=69 Participants
Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.
Financial Incentives
Daily feedback
|
Daily Lottery
n=70 Participants
Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.
Financial Incentives
Daily feedback
|
Loss Framing
n=70 Participants
The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.
Financial Incentives
Daily feedback
|
|---|---|---|---|---|
|
Proportion of Days Each Individual Walks 7000 Steps Per Day or More
Intervention
|
0.30 Proportion of participant-days
Interval 0.22 to 0.37
|
0.35 Proportion of participant-days
Interval 0.28 to 0.42
|
0.36 Proportion of participant-days
Interval 0.29 to 0.43
|
0.45 Proportion of participant-days
Interval 0.38 to 0.52
|
|
Proportion of Days Each Individual Walks 7000 Steps Per Day or More
Follow-up
|
0.24 Proportion of participant-days
Interval 0.18 to 0.31
|
0.25 Proportion of participant-days
Interval 0.19 to 0.31
|
0.23 Proportion of participant-days
Interval 0.17 to 0.3
|
0.30 Proportion of participant-days
Interval 0.24 to 0.37
|
SECONDARY outcome
Timeframe: Throughout the 6 month studySecondary outcomes include average number of steps each individual takes per day throughout the 13-week intervention and additional 13-week follow-up periods.
Outcome measures
| Measure |
Control
n=70 Participants
The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved their goal for the prior day.
Daily feedback
|
Gain Framing
n=69 Participants
Participants will be told that they will earn money for each day they walk at least 7000 steps. Each participant will receive either an email or text message (based on the participant's preference) stating whether or not he/she achieved the goal for the prior day and can collect the earnings. Non-adherent participants will receive messages about how much they would have earned had they met their target step goal.
Financial Incentives
Daily feedback
|
Daily Lottery
n=70 Participants
Each participant will be entered into a lottery daily, but participants will only be eligible to collect their winnings if they walked at least 7000 steps the day before. Participants will receive either an email or text message (based on the participant's preference) stating whether or not they won the lottery and if they met their target step goal. If both occur, the participant will be told how much money he or she won. Non-adherent participants will receive messages about how much they would have won had they met the target step goal.
Financial Incentives
Daily feedback
|
Loss Framing
n=70 Participants
The participants will be told that their account has been credited a certain amount of money for the upcoming 30 days. However, for each day they do not meet their goal of at least 7000 steps, they will lose a small portion of that money. The participant will receive either an email or text message (based on the participant's preference) stating whether the participant achieved the goal for the prior day. Non-adherent participants will receive messages about how much the participant would have kept had they met the target step goal.
Financial Incentives
Daily feedback
|
|---|---|---|---|---|
|
Average Number of Steps Per Day
Intervention
|
5031 Steps per day
Interval 4406.0 to 5656.0
|
5406 Steps per day
Interval 4799.0 to 6013.0
|
5251 Steps per day
Interval 4625.0 to 5876.0
|
5880 Steps per day
Interval 5265.0 to 6497.0
|
|
Average Number of Steps Per Day
Follow-up
|
4539 Steps per day
Interval 3916.0 to 5162.0
|
4692 Steps per day
Interval 4084.0 to 5301.0
|
4529 Steps per day
Interval 3901.0 to 5158.0
|
5065 Steps per day
Interval 4466.0 to 5664.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gain Framing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Daily Lottery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Loss Framing
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
Dr. Mitesh S. Patel
Division of General Internal Medicine, Perelman School of Medicine, University of Pennsylvania
Phone: 215-898-3367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place