Sedentary LifestyleNCT02030080

Way to Be Active IV (Framing vs Incentives)

A study testing Financial incentives, Teams and Framing of feedback in people with Sedentary Lifestyle, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Sedentary Lifestyle
What is being tested?: Financial incentives, Teams and Framing of feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than 18.
Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Who cannot join

Pregnant or lactating
Currently participating in another physical activity study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 09104

Other trials in United States

About this study

Official title: A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing vs Incentives

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.

Conditions: Sedentary Lifestyle
Being tested: Financial incentives, Teams, Framing of feedback, Daily Feedback
Keywords: Pedometers, Walking, Financial incentives, Sedentary lifestyle, Behavioral economics
Medical subject headings: Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Financial incentivesBehavioural
TeamsBehavioural
Framing of feedbackBehavioural
Daily FeedbackBehavioural
Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.

Study groups in NCT02030080
Study group	Role	What they receive
Feedback 50th Percentile	Active comparator	At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. Receives: Behavioral: Teams; Behavioral: Daily Feedback
Feedback 75th Percentile	Experimental	At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. Receives: Behavioral: Teams; Behavioral: Framing of feedback; Behavioral: Daily Feedback
Feedback 50th Percentile + Lottery	Experimental	At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. 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. Receives: Behavioral: Financial incentives; Behavioral: Teams; Behavioral: Daily Feedback
Feedback 75th Percentile + Lottery	Experimental	At the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. 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. Receives: Behavioral: Financial incentives; Behavioral: Teams; Behavioral: Framing of feedback; Behavioral: Daily Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Days a Participant Walks 7000 Steps or More
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. Below we report the highest mean proportions found.
Measured: Throughout 6-month study

Secondary outcomes (1)

Average Number of Steps Per Day
Secondary outcomes include average number of steps per day during the incentive period (first 3 months) and follow-up period (second 3 months).
Measured: Throughout the 6-month study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Sep 2014

First posted8 Jan 2014 (estimated)
Study startJan 2014
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030080
Sponsor's protocol ID: 819371
Status last verified: Dec 2017
First submitted: 20 Dec 2013
Last updated: 29 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Patel MS, Volpp KG, Rosin R, Bellamy SL, Small DS, Fletcher MA, Osman-Koss R, Brady JL, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Asch DA. A Randomized Trial of Social Comparison Feedback and Financial Incentives to Increase Physical Activity. Am J Health Promot. 2016 Jul;30(6):416-24. doi: 10.1177/0890117116658195. Epub 2016 Jul 15.
PubMed 27422252

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Future School of Comprehensive Well-Being
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RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
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Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
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Not yet recruiting
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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Framing vs Incentives
ClinicalTrials.gov ID: NCT02030080
Acronym / sponsor ID: 819371
Conditions: Sedentary Lifestyle
Keywords: Pedometers, Walking, Financial incentives, Sedentary lifestyle, Behavioral economics
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Jan 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 8 Jan 2014 (estimated)
Results: Posted 4 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Feedback 50th Percentile	Active comparator	Behavioral: Teams, Behavioral: Daily FeedbackAt the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm.
Feedback 75th Percentile	Experimental	Behavioral: Teams, Behavioral: Framing of feedback, Behavioral: Daily FeedbackAt the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm.
Feedback 50th Percentile + Lottery	Experimental	Behavioral: Financial incentives, Behavioral: Teams, Behavioral: Daily FeedbackAt the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 50th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. 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.
Feedback 75th Percentile + Lottery	Experimental	Behavioral: Financial incentives, Behavioral: Teams, Behavioral: Framing of feedback, Behavioral: Daily FeedbackAt the end of each week, participants will be told the average daily step count for their team for the previous week. They will also be told the average for the 75th percentile in their arm. If their team's average daily step count is ≥ 7000 steps, they'll be eligible to collect winnings from a weekly lottery. 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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age greater than 18.
Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Key exclusion criteria (2 listed)

Pregnant or lactating
Currently participating in another physical activity study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Financial incentives	Behavioural	Feedback 50th Percentile + Lottery, Feedback 75th Percentile + Lottery
Teams	Behavioural	Feedback 50th Percentile, Feedback 50th Percentile + Lottery, Feedback 75th Percentile, Feedback 75th Percentile + Lottery
Framing of feedback	Behavioural	Feedback 75th Percentile, Feedback 75th Percentile + Lottery
Daily FeedbackParticipants will be given daily feedback on whether or not they walked 7000 steps or more the day before.	Behavioural	Feedback 50th Percentile, Feedback 50th Percentile + Lottery, Feedback 75th Percentile, Feedback 75th Percentile + Lottery

Primary outcome

Proportion of Days a Participant Walks 7000 Steps or More
Time frame: Throughout 6-month study
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. Below we report the highest mean proportions found.

1 secondary outcome

Average Number of Steps Per Day
Time frame: Throughout the 6-month study

Results and safety

Results posted to the registry on 4 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Feedback 50th Percentile	100	100
Feedback 75th Percentile	64	64
Feedback 50th Percentile + Lottery	80	80
Feedback 75th Percentile + Lottery	44	42

Primary outcome: Proportion of Days a Participant Walks 7000 Steps or More

Time frame: Throughout 6-month study. Mean (95% Confidence Interval). Unit: Mean proportion

Measure	Feedback 50th Percentile n = 100	Feedback 75th Percentile n = 64	Feedback 50th Percentile + Lottery n = 80	Feedback 75th Percentile + Lottery n = 42
Value	0.30 (0.21 to 0.38)	0.27 (0.17 to 0.37)	0.45 (0.35 to 0.54)	0.38 (0.25 to 0.50)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Feedback 50th Percentile	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Feedback 75th Percentile	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Feedback 50th Percentile + Lottery	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Feedback 75th Percentile + Lottery	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): Participants are from single location and their activity was not tracked when not carrying smartphones. Randomization resulted in uneven # of participants; potentially limiting power for arms with \< 70 subjects. Did not have baseline data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27422252Patel MS, Volpp KG, Rosin R, Bellamy SL, Small DS, Fletcher MA, Osman-Koss R, Brady JL, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Asch DA. A Randomized Trial of Social Comparison Feedback and Financial Incentives to Increase Physical Activity. Am J Health Promot. 2016 Jul;30(6):416-24. doi: 10.1177/0890117116658195. Epub 2016 Jul 15.

Related trials for Sedentary Lifestyle

Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mitesh Patel, MD, MBA study director

University of Pennsylvania

Kevin Volpp, MD, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Financial incentives, Teams and Framing of feedback in people with Sedentary Lifestyle, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Days a Participant Walks 7000 Steps or More (time frame: Throughout 6-month study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030080, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.