Sedentary LifestyleNCT01043757
Financial Incentives for Increasing Exercise
A study testing Financial incentives for increasing physical exercise in people with Sedentary Lifestyle and Obesity, run by Harvard University at 1 site in United States.
Trial summary
Participants will be employees of Genzyme who volunteer to participate in a study on motivating healthy behaviors, involving giving them goals for taking a certain number of steps per day, and increasing that number over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Obesity
- What is being tested?
- Financial incentives for increasing physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 28 or higher
- Pass the Par-Q
- answer "No" to all Par-Q questions
- at least 18 years of age
- has computer at home or work with compatible operating system (i.e. windows 2000, windows xp, windows vista, osX 10.3-10.5), internet access, and usb port
Who cannot join
- Anyone who does not meet all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Financial Incentives for Increasing Exercise
Participants will be employees of Genzyme who volunteer to participate in a study on motivating healthy behaviors, involving giving them goals for taking a certain number of steps per day, and increasing that number over time. Participants will wear pedometers and upload their data to a website that allows them to monitor their progress, and have the opportunity to win money based on meeting their step goals.
Interested employees will schedule a day and time to complete a health screening at a "Health Fair" at their place of employment, to ensure that they are healthy enough to participate; at this time participants will also complete the investigators baseline dependent measures, and receive a pedometer. After a one-week baseline period during which they wear the pedometer and the investigators establish their typical number of steps per day, eligible participants will then be assigned to one of four treatments - a "no incentive" control condition, and three conditions in which they are entered into different kinds of monetary lotteries if they have met their step goals for that day. Participants' initial goal will be based on their steps during the baseline period, and the goal will increase by 250 steps each week, for a total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but participants continue to wear their pedometers and upload their data for an additional 6 months. At 3 months, 6 months, and then at the study end at 9 months, participants again complete the investigators dependent measures at follow-up Health Fairs at their place of employment.
- Conditions
- Sedentary Lifestyle, Obesity
- Being tested
- Financial incentives for increasing physical exercise
- Keywords
- Sedentary lifestyle, physical exercise, behavioral economics, financial incentives, obesity
- 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 incentives for increasing physical exerciseBehavioural
Throughout the 12-week intervention, participants will receive step goals. The step goals will increase by 250 steps per week, The intervention will last a total of 12 weeks. After each seven-day week, step goals will increase by an additional 250 steps - thus over the 12 weeks, participants will be asked to increase their daily step count by 3,000. Participants will receive financial incentives to attain these step goals; the incentive schemes differ according to intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 1) Control Group. Receives daily step goals via emails and has access to the study website to allow them to track their progress. Eligible for check-in incentives. Receives: Behavioral: Financial incentives for increasing physical exercise |
| Fixed | Experimental | Receives control intervention plus are incentivized to attain their daily step goals through daily lotteries:
Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot. Participants who meet their step goal for the day and who upload their data will be entered into the same lottery each day, where the small jackpot is $10 and the large jackpot is $100. Receives: Behavioral: Financial incentives for increasing physical exercise |
| Ascending | Experimental | Receives control intervention plus incentivized to attain daily step goals through lotteries:
Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot.
Participants can increase their daily jackpots by meeting their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $4 and the large jackpot is $40; if they successfully meet their step goal on the first day of the week, the jackpots for the second day increase to $6/$60, and so on such that if they reach their goals each day, the jackpots on day seven will reach $16/$160. Receives: Behavioral: Financial incentives for increasing physical exercise |
| Decreasing | Experimental | Receives control intervention plus incentivized to attain daily step goals through lotteries:
Daily drawing procedure same as Ascending condition; structure of incentives is different: Participants can decrease their daily jackpots by failing to meet their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $16 and the large jackpot is $160; if they successfully meet their step goal on the first day of the week, the jackpots will remain at $16/$160; if they do not meet their goal the jackpots will decrease to $14/$140, and so on such that if they fail to reach their goals each day, the jackpots on day seven will decrease to $4/$40. Receives: Behavioral: Financial incentives for increasing physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Measured: 12 weeks
Secondary outcomes (8)
RAND 36-item Health Survey
Measured: 3mo, 6mo, 9mo
Health Stress questionnaire
Measured: 3mo, 6mo, 9mo
Emotional, Work, and Financial Attitudes questionnaire
Measured: 3mo, 6mo, 9mo
Weight loss
Measured: 3mo, 6mo, 9mo
Hemoglobin A1C
Measured: 6mo
Health behaviors questionnaire
Measured: 3mo, 6mo, 9mo
Word of mouth
Measured: 6mo, 9mo
Physical activity
Measured: 6mo, 9mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2013 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: The study was stopped prior to recruitment due to logistical issues with the company in which it was going to be run.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield, Genzyme, a Sanofi Company, Partners HealthCare
- Investigators
- Michael I. Norton, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043757
- Sponsor's protocol ID
- HBS-MN01
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2010
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Financial Incentives for Increasing Exercise
- ClinicalTrials.gov ID
- NCT01043757
- Acronym / sponsor ID
- HBS-MN01
- Conditions
- Sedentary Lifestyle, Obesity
- Keywords
- Sedentary lifestyle, physical exercise, behavioral economics, financial incentives, obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped prior to recruitment due to logistical issues with the company in which it was going to be run.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield, Genzyme, a Sanofi Company, Partners HealthCare
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be employees of Genzyme who volunteer to participate in a study on motivating healthy behaviors, involving giving them goals for taking a certain number of steps per day, and increasing that number over time. Participants will wear pedometers and upload their data to a website that allows them to monitor their progress, and have the opportunity to win money based on meeting their step goals.
Interested employees will schedule a day and time to complete a health screening at a "Health Fair" at their place of employment, to ensure that they are healthy enough to participate; at this time participants will also complete the investigators baseline dependent measures, and receive a pedometer. After a one-week baseline period during which they wear the pedometer and the investigators establish their typical number of steps per day, eligible participants will then be assigned to one of four treatments - a "no incentive" control condition, and three conditions in which they are entered into different kinds of monetary lotteries if they have met their step goals for that day. Participants' initial goal will be based on their steps during the baseline period, and the goal will increase by 250 steps each week, for a total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but participants continue to wear their pedometers and upload their data for an additional 6 months. At 3 months, 6 months, and then at the study end at 9 months, participants again complete the investigators dependent measures at follow-up Health Fairs at their place of employment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Financial incentives for increasing physical exercise1) Control Group. Receives daily step goals via emails and has access to the study website to allow them to track their progress. Eligible for check-in incentives. |
| Fixed | Experimental | Behavioral: Financial incentives for increasing physical exerciseReceives control intervention plus are incentivized to attain their daily step goals through daily lotteries: Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot. Participants who meet their step goal for the day and who upload their data will be entered into the same lottery each day, where the small jackpot is $10 and the large jackpot is $100. |
| Ascending | Experimental | Behavioral: Financial incentives for increasing physical exerciseReceives control intervention plus incentivized to attain daily step goals through lotteries: Each day, we will draw a two-digit number. If the first digit OR the second digit of this daily number matches the participant's lucky number, they win the small jackpot. If both digits match, they receive the large jackpot. Participants can increase their daily jackpots by meeting their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $4 and the large jackpot is $40; if they successfully meet their step goal on the first day of the week, the jackpots for the second day increase to $6/$60, and so on such that if they reach their goals each day, the jackpots on day seven will reach $16/$160. |
| Decreasing | Experimental | Behavioral: Financial incentives for increasing physical exerciseReceives control intervention plus incentivized to attain daily step goals through lotteries: Daily drawing procedure same as Ascending condition; structure of incentives is different: Participants can decrease their daily jackpots by failing to meet their step goals. Those who meet their goal for the first day of the week and who upload their data will be entered into a lottery where the small jackpot is $16 and the large jackpot is $160; if they successfully meet their step goal on the first day of the week, the jackpots will remain at $16/$160; if they do not meet their goal the jackpots will decrease to $14/$140, and so on such that if they fail to reach their goals each day, the jackpots on day seven will decrease to $4/$40. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI of 28 or higher
- Pass the Par-Q
- answer "No" to all Par-Q questions
- at least 18 years of age
- has computer at home or work with compatible operating system (i.e. windows 2000, windows xp, windows vista, osX 10.3-10.5), internet access, and usb port
Key exclusion criteria (1 listed)
- Anyone who does not meet all of the inclusion criteria
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 for increasing physical exerciseThroughout the 12-week intervention, participants will receive step goals. The step goals will increase by 250 steps per week, The intervention will last a total of 12 weeks. After each seven-day week, step goals will increase by an additional 250 steps - thus over the 12 weeks, participants will be asked to increase their daily step count by 3,000. Participants will receive financial incentives to attain these step goals; the incentive schemes differ according to intervention arm. | Behavioural | Ascending, Control, Decreasing, Fixed |
Primary outcome
Physical activity
Time frame: 12 weeks
8 secondary outcomes
RAND 36-item Health Survey
Time frame: 3mo, 6mo, 9mo
Health Stress questionnaire
Time frame: 3mo, 6mo, 9mo
Emotional, Work, and Financial Attitudes questionnaire
Time frame: 3mo, 6mo, 9mo
Weight loss
Time frame: 3mo, 6mo, 9mo
Hemoglobin A1C
Time frame: 6mo
Health behaviors questionnaire
Time frame: 3mo, 6mo, 9mo
Word of mouth
Time frame: 6mo, 9mo
Physical activity
Time frame: 6mo, 9mo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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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.
Michael I. Norton, PhD principal investigator
Harvard University
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 for increasing physical exercise in people with Sedentary Lifestyle and Obesity, run by Harvard University 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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Jun 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2015.