HealthyNCT01410812
Tying Devices as a Means of Increasing Exercise
A study testing Suggested Tying Intervention and Forced Tying Intervention in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators propose that healthy behaviors such as exercise could be increased through the use of tying devices - mechanisms that force a coupling of addictive activities (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior (exercise). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Suggested Tying Intervention and Forced Tying Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable health as determined by the screening of their medical history
- Own an iPod
- An interest in exercising more regularly
- Belong to the Pottruck Gym at University of Pennsylvania
- Interested in exercising more through the use of aerobic exercise machines
Who cannot join
- Recent myocardial infraction
- congestive heart failure
- uncontrolled hypertension
- self-report of 6 or more alcoholic beverages per day or use of any illicit drugs
- bulimia nervosa or related behaviors
- diabetes medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The investigators propose that healthy behaviors such as exercise could be increased through the use of tying devices - mechanisms that force a coupling of addictive activities (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior (exercise).
Read the detailed description
The study will test the effect of the following treatments as a means of increasing gym attendance over 10 weeks: 1. Participants receive access to 4 iTunes audio novels on their own iPods and prompted to listen to those novels only when exercising at the gym; 2: Participants receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym; 3: Participants receive weekly emails asking them about their exercise.
- Conditions
- Healthy
- Being tested
- Control, Suggested Tying Intervention, Forced Tying Intervention
- Keywords
- Interest in exercising more
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Receive weekly emails asking participants about their exercise and receive cash.
Suggested Tying InterventionBehavioural
Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym
Forced Tying InterventionBehavioural
Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym.
| Study group | Role | What they receive |
|---|---|---|
| Suggested Tying | Experimental | Receive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance. Receives: Behavioral: Suggested Tying Intervention |
| Forced Tying | Experimental | Receives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance. Receives: Behavioral: Forced Tying Intervention |
| Control | Experimental | Control group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Weekly Gym Attendance From Baseline to Week 9
Measured: 9 weeks
Secondary outcomes (1)
Dollar Amount Participants Would Pay for Enrollment
Willingness to pay is measured as the dollar amount a participant would pay to be enrolled in a program such as the treatment. Participant who would pay more are said to be more willing to pay, as opposed to those who would pay less or not at all.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionSep 2012
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.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine L. Milkman, Ph.D., Principal investigator, University of PennsylvaniaJulia A Minson, Principal investigator, University of PennsylvaniaKevin G.M. Volpp, MD, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410812
- Sponsor's protocol ID
- 813970
- Status last verified
- Jan 2018
- First submitted
- 3 Aug 2011
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tying Devices as a Means of Increasing Exercise
- ClinicalTrials.gov ID
- NCT01410812
- Acronym / sponsor ID
- 813970
- Conditions
- Healthy
- Keywords
- Interest in exercising more
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose that healthy behaviors such as exercise could be increased through the use of tying devices - mechanisms that force a coupling of addictive activities (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior (exercise).
Detailed description
The study will test the effect of the following treatments as a means of increasing gym attendance over 10 weeks: 1. Participants receive access to 4 iTunes audio novels on their own iPods and prompted to listen to those novels only when exercising at the gym; 2: Participants receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym; 3: Participants receive weekly emails asking them about their exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suggested Tying | Experimental | Behavioral: Suggested Tying InterventionReceive same treatments as control group, but instead of receiving cash they receive 4 iTunes audio novels for their own iPods. Further, they are prompted to try to listen to those novels only when exercising at the gym in order to increase their attendance. |
| Forced Tying | Experimental | Behavioral: Forced Tying InterventionReceives same treatment as the control group. However, in addition to receiving the cash, they also receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym. They are told they may only listen to these novels only when at the gym in order to increase their attendance. |
| Control | Experimental | Behavioral: ControlControl group of participants who do not receive any intervention but are weighed at the beginning and end of a 10 week period and receive weekly emails asking them about their exercise. They also receive the equivalent cash value of 4 iTunes audio novels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable health as determined by the screening of their medical history
- Own an iPod
- An interest in exercising more regularly
- Belong to the Pottruck Gym at University of Pennsylvania
- Interested in exercising more through the use of aerobic exercise machines
Key exclusion criteria (6 listed)
- Recent myocardial infraction
- congestive heart failure
- uncontrolled hypertension
- self-report of 6 or more alcoholic beverages per day or use of any illicit drugs
- bulimia nervosa or related behaviors
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 |
|---|---|---|
| ControlReceive weekly emails asking participants about their exercise and receive cash. | Behavioural | Control |
| Suggested Tying InterventionParticipants receive 4 iTunes audio novels for their own iPods to listen to only at the gym | Behavioural | Suggested Tying |
| Forced Tying InterventionParticipants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym. | Behavioural | Forced Tying |
Primary outcome
Average Weekly Gym Attendance From Baseline to Week 9
Time frame: 9 weeks
1 secondary outcome
Dollar Amount Participants Would Pay for Enrollment
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katherine L. Milkman, Ph.D. principal investigator
University of Pennsylvania
Julia A Minson principal investigator
University of Pennsylvania
Kevin G.M. Volpp, MD, Ph.D. 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 Suggested Tying Intervention and Forced Tying Intervention in people with Healthy, 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 5 inclusion and 6 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 19 Dec 2018. 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 19 Dec 2018). 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?
Average Weekly Gym Attendance From Baseline to Week 9 (time frame: 9 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 19 Dec 2018.