- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02030132
Way to Be Active V (Framing vs. Forgiveness)
A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing vs. Forgiveness
Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.
The primary outcome measure is the proportion of 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. Secondary outcomes will include the average steps walked per day.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than 18.
- Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps
Exclusion Criteria:
- Pregnant or lactating
- Participating in another physical activity study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Feedback 50th Percentile
At the end of each week, participants will be told (by email or text, based on the participant's preference) the team's average daily step count for the previous week based on all 7 days.
They will also be told the average for the 50th percentile in their arm.
If the team's average daily step count is ≥ 7000 steps, the team will be eligible for the weekly lottery.
|
For the first three months of the study, a weekly lottery will be held.
Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings.
Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.
Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
|
|
Experimental: Feedback 75th Percentile
At the end of each week, participants will be told (by email or text, based on the participant's preference) the team's average daily step count for the previous week based on all 7 days.
They will also be told the average for the 75th percentile in their arm.
If the team's average daily step count is ≥ 7000 steps, the team will be eligible for the weekly lottery.
|
For the first three months of the study, a weekly lottery will be held.
Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings.
Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.
Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
|
|
Experimental: Feedback 50th Percentile + Forgiveness
At the end of each week, participants will be told (by email or text, based on the participant's preference) the average team's average daily step count for the previous week based on the best 5 of 7 days.
They will also be told the average for the 50th percentile in their arm.
If the team's average daily step count (best 5 of 7 days) is ≥ 7000 steps, the team will be eligible for the weekly lottery.
|
For the first three months of the study, a weekly lottery will be held.
Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings.
Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.
Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
|
|
Experimental: Feedback 75th Percentile + Forgiveness
At the end of each week, participants will be told (by email or text, based on the participant's preference) the team's average daily step count for the previous week based on the best 5 of 7 days.
They will also be told the average for the 75th percentile in their arm.
If the team's average daily step count (best 5 of 7 days) is ≥ 7000 steps, the team will be eligible for the weekly lottery.
|
For the first three months of the study, a weekly lottery will be held.
Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings.
Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.
Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of days an individual walks 7000 steps or more
Time Frame: End of study - 6 months after enrollment
|
The primary outcome measure is the proportion of 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.
|
End of study - 6 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average number of steps per day and week
Time Frame: End of study- 6 months after enrollment
|
Secondary outcomes include average number of steps per day and week during the intervention (first 3 months) and follow-up (second 3 months) periods.
|
End of study- 6 months after enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity
Time Frame: End of study- 6 months after enrollment
|
Changes in physical activity as determined by validated surveys.
|
End of study- 6 months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin M Volpp, MD, PhD, University of Pennsylvania
- Study Director: Mitesh Patel, MD, MBA, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 819370
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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