Sedentary LifestyleNCT02030119

Way to Be Active III (Framing Incentives)

A study testing Financial Incentives and Daily 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 and Daily feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 281 participants
Where: 1 siteUnited States
Study dates: Feb 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

A score of "high" on the International Physical Activity Questionnaire (IPAQ) activity level scale
BMI less than 27
Pregnant or lactating
Participation 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 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, Daily feedback
Keywords: Sedentary lifestyle, Pedometers, Obesity, Physical Activity, Financial Incentives, Behavioral Economics
Medical subject headings: Sedentary Behavior, Obesity, Motor Activity

What participants receive

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

Financial IncentivesBehavioural
Daily feedbackBehavioural

Study groups in NCT02030119
Study group	Role	What they receive
Control	Active comparator	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. Receives: Behavioral: Daily feedback
Gain Framing	Experimental	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. Receives: Behavioral: Financial Incentives; Behavioral: Daily feedback
Loss Framing	Experimental	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. Receives: Behavioral: Financial Incentives; Behavioral: Daily feedback
Daily Lottery	Experimental	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. Receives: Behavioral: Financial Incentives; Behavioral: Daily feedback

What is being measured

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

Proportion of Days Each Individual Walks 7000 Steps Per Day or More
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.
Measured: Throughout the 6 month study

Secondary outcomes (1)

Average Number of Steps Per Day
Secondary outcomes include average number of steps each individual takes per day throughout the 13-week intervention and additional 13-week follow-up periods.
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.

Feb 2014Sep 2014

First posted8 Jan 2014 (estimated)
Study startFeb 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: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030119
Sponsor's protocol ID: 819149
Status last verified: Sep 2017
First submitted: 20 Dec 2013
Last updated: 2 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.
PubMed 26881417

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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Active, not recruiting
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
Sedentary Behavior, Acute Exercise
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 2 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 Incentives
ClinicalTrials.gov ID: NCT02030119
Acronym / sponsor ID: 819149
Conditions: Sedentary Lifestyle
Keywords: Sedentary lifestyle, Pedometers, Obesity, Physical Activity, Financial Incentives, Behavioral Economics
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Feb 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 8 Jan 2014 (estimated)
Results: Posted 2 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
Control	Active comparator	Behavioral: Daily feedbackThe 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.
Gain Framing	Experimental	Behavioral: Financial Incentives, Behavioral: Daily feedbackParticipants 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.
Loss Framing	Experimental	Behavioral: Financial Incentives, Behavioral: Daily feedbackThe 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.
Daily Lottery	Experimental	Behavioral: Financial Incentives, Behavioral: Daily feedbackEach 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.

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 (4 listed)

A score of "high" on the International Physical Activity Questionnaire (IPAQ) activity level scale
BMI less than 27
Pregnant or lactating
Participation 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	Daily Lottery, Gain Framing, Loss Framing
Daily feedback	Behavioural	Control, Daily Lottery, Gain Framing, Loss Framing

Primary outcome

Proportion of Days Each Individual Walks 7000 Steps Per Day or More
Time frame: Throughout the 6 month study
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.

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 2 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
Control	70	67
Gain Framing	70	68
Daily Lottery	71	65
Loss Framing	70	67

Primary outcome: Proportion of Days Each Individual Walks 7000 Steps Per Day or More

Time frame: Throughout the 6 month study. Mean (95% Confidence Interval). Unit: Proportion of participant-days

Measure	Control n = 70	Gain Framing n = 69	Daily Lottery n = 70	Loss Framing n = 70
Intervention	0.30 (0.22 to 0.37)	0.35 (0.28 to 0.42)	0.36 (0.29 to 0.43)	0.45 (0.38 to 0.52)
Follow-up	0.24 (0.18 to 0.31)	0.25 (0.19 to 0.31)	0.23 (0.17 to 0.30)	0.30 (0.24 to 0.37)

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
Control	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Gain Framing	0 of 69 (0%)	0 of 69 (0%)	0 of 69
Daily Lottery	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Loss Framing	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Limitations and caveats (from the sponsor): Subjects were from single Philadelphia employer; ppts were required to have a smartphone, and their physical activity was not tracked when they did not have smartphone on them; we did not collect baseline data for step counts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26881417Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.

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.

Kevin M Volpp, MD, PhD principal investigator

University of Pennsylvania

Mitesh Patel, MD, MBA study director

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 and Daily 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 4 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 2 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 2 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 Each Individual Walks 7000 Steps Per Day or More (time frame: Throughout the 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 NCT02030119, 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 2 Dec 2017.