Tying Devices as a Means of Increasing Exercise

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01410812
• Collaborator: (none)
• Enrollment: 226
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 18.8

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Control; Behavioral: Suggested Tying Intervention; Behavioral: Forced Tying Intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 226 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Tying Devices as a Means of Increasing Exercise
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suggested Tying 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.	Behavioral: Suggested Tying Intervention; Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym
Experimental: Forced Tying 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.	Behavioral: Forced Tying Intervention; 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.
Experimental: Control 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	Behavioral: Control; Receive weekly emails asking participants about their exercise and receive cash.

Outcome Measures

Primary Outcome Measures

1. Average Weekly Gym Attendance From Baseline to Week 9 [9 weeks]

Secondary Outcome Measures

1. Dollar Amount Participants Would Pay for Enrollment [9 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Katherine L. Milkman, Ph.D., University of Pennsylvania
• Principal Investigator: Julia A Minson, University of Pennsylvania
• Principal Investigator: Kevin G.M. Volpp, MD, Ph.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01410812
• Other Study ID Numbers: 813970; NCT01421329
• First Posted: Aug 5, 2011
• Last Update Posted: Dec 19, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by University of Pennsylvania: Interest in exercising more

Study Results

Participant Flow

Arm/Group Title	Suggested Tying	Forced Tying	Control
Arm/Group Description	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. Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym	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. Forced Tying Intervention: 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.	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 Control: Receive weekly emails asking participants about their exercise and receive cash.
Period Title: Overall Study
STARTED	75	75	76
COMPLETED	75	75	76
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Suggested Tying	Forced Tying	Control	Total
Arm/Group Description	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. Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym	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. Forced Tying Intervention: 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.	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 Control: Receive weekly emails asking participants about their exercise and receive cash.	Total of all reporting groups
Overall Participants	75	75	76	226
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	75 100%	75 100%	76 100%	226 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	50 66.7%	51 68%	48 63.2%	149 65.9%
Male	25 33.3%	24 32%	28 36.8%	77 34.1%

Outcome Measures

1. Primary Outcome

Title	Average Weekly Gym Attendance From Baseline to Week 9
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suggested Tying	Forced Tying	Control
Arm/Group Description	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. Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym	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. Forced Tying Intervention: 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.	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 Control: Receive weekly emails asking participants about their exercise and receive cash.
Measure Participants	75	75	76
Mean (95% Confidence Interval) [Average Weekly Gym Attendance]	1.21	1.42	0.94

2. Secondary Outcome

Title	Dollar Amount Participants Would Pay for Enrollment
Description	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.
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

Some of the participants failed to respond for this outcome measure.

Arm/Group Title	Suggested Tying	Forced Tying	Control
Arm/Group Description	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. Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym	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. Forced Tying Intervention: 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.	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 Control: Receive weekly emails asking participants about their exercise and receive cash.
Measure Participants	71	69	71
Mean (Standard Deviation) [Dollars]	4.77 (7.24)	6.01 (8.31)	9.87 (14.55)

Adverse Events

Arm/Group Title	Suggested Tying		Forced Tying		Control
Arm/Group Description	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. Suggested Tying Intervention: Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym		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. Forced Tying Intervention: 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.		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 Control: Receive weekly emails asking participants about their exercise and receive cash.
All Cause Mortality
	Suggested Tying		Forced Tying		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Suggested Tying		Forced Tying		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)		0/76 (0%)
Other (Not Including Serious) Adverse Events
	Suggested Tying		Forced Tying		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)		0/76 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.