Way to Be Active 2 (Lotteries)

February 11, 2019 updated by: University of Pennsylvania

A Randomized Trial of Behavioral Economic Interventions to Improve Physical Activities: Lottery 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.

Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. We will use a minimum age of 18 to ensure all individuals are legally able to consent.
  • 2. Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

  • Conditions that would make participation infeasible: 1a. Inability to consent 1b. Illiteracy and/or inability to speak, read, and write English 1c. Participation in another research study 2. Conditions that would make participation unsafe: 2a. Current treatment for drug or alcohol use 2b. Consumption of at least 5 alcoholic drinks per day 2c. Myocardial infarction or stroke within the past 6 months 2d. Current addiction to prescription medicines or street drugs 2e. Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia) 2f. Pregnant or currently breastfeeding 2g. Metastatic cancer 2h. Unstable medical conditions that would likely prevent the participant from completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: Basic Lottery

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 day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:

About a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.
Behavioral: Basic Lottery
Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.
Experimental: Combined Lottery

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 day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:

About a 1 in 5 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.
Behavioral: Combined Lottery
Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.
Experimental: Jackpot Lottery

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 day a lottery will be held, and participants will be eligible to collect monetary rewards only if the participant met the step goal the day before. The names of the winners will be announced during each lottery. The daily lotteries are as follows:

About a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.
Behavioral: Jackpot Lottery
Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Days a Minimum Activity of 7000 Steps or More is Achieved During Intervention
Time Frame: End of study- 6 months of after enrollment
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 using incentives followed by 3 months of follow-up without incentives. All available data will be analyzed, and missing will be treated as true missing data points. Secondary outcomes will include the average steps walked per day.
End of study- 6 months of after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Number of Steps Per Day During Intervention
Time Frame: End of study- 6 months after enrollment
Secondary outcomes include average number of steps per day during intervention (with incentives) and follow up periods (without incentives).
End of study- 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin M Volpp, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 819103

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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