- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342471
Physical Activity and Leisure-time Study (PALS) (PALS)
October 10, 2012 updated by: University of Tennessee
TV Commercial Stepping: Can America's Top Sedentary Activity be Made More Active
Physical inactivity is a major public health problem and a primary contributing factor to the obesity epidemic.
While most Americans do not meet the physical activity (PA) guidelines (30 min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site "lack of time" as a barrier for engaging in PA.
The Physical Activity and Leisure-time Study examines an approach convert sedentary TV watching into active TV watching time by having adults step in place during commercials (TV commercial stepping).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial will examine the effects of a PA prescription of TV commercial stepping for at least 90 min/day of TV programming, with that of walking at least 30 min/day (30 min walk) on daily step counts, TV viewing, and diet during a 24 week PA intervention.
Sedentary, overweight or obese, adults will be randomly assigned to either the TV commercial stepping, or 30 min walk group during a 24-week behavioral PA intervention.
Both groups will attend 8 sessions, but receive different PA goals.
PA, TV watching time, diet, and anthropometric data will be collected at 0, 12, and 24 weeks.
It is hypothesized that the TV commercial stepping condition will, show an equal increase in PA at 12 and 24 weeks as compared to the 30-min walk condition.
Neither group is hypothesized to demonstrate changes in TV viewing time, dietary intake, or weight.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 1
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
-
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Tennessee
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Knoxville, Tennessee, United States, 37920
- HPER Building, 1914 Andy Holt Ave.
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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
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 25 to 65 years of age
- BMI between 25 and 45 kg/m2
- watch ≥14 hours per week of TV
- ability to follow instructions and record data
- ability to walk 1/4 mile without stopping
Exclusion Criteria:
- history of myocardial infraction, angina, stroke, heart failure, or uncontrolled cardiac arrhythmias
- a resting blood pressure greater than 180 mm Hg systolic and/or 100 mm Hg diastolic
- other physical or medical limitations for engaging in physical activity
- no television in the home
- baseline physical activity level exceeding 7,499 steps per day as determined by the Omron pedometer
- currently participating in a program to increase PA
- intended to move outside the East Tennessee area within the time frame of the intervention
- were pregnant, lactating, less than 6 months post-partum, or planned to become pregnant during the time frame of the intervention
- unwilling to attend group intervention meetings, assessments or to complete an activity diary for the duration of 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 30-min walk
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week.
Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
|
Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week.
Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day.
Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
Other Names:
|
Experimental: TV commercial stepping
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week.
Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
|
Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week.
Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day.
Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity (Steps/Day)
Time Frame: 0 and 6 months
|
Change in pedometer measured steps per day between 0 and 6 months
|
0 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Energy Intake
Time Frame: 0 and 6 months
|
Change in total energy intake(kcals/day) between 0 and 6 months
|
0 and 6 months
|
TV Related Energy Intake
Time Frame: 0 and 6 months
|
Change in energy intake (kcals/day) while watching TV between 0 and 6 months
|
0 and 6 months
|
Weight
Time Frame: 0 and 6 months
|
Change in weight in kgs between 0 and 6 months
|
0 and 6 months
|
TV Viewing Time
Time Frame: 0 and 6 months
|
Change in self-reported TV viewing time per day between 0 and 6 months
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0 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeremy A Steeves, MS, University of Tennessee
- Study Chair: Dixie Lee Thompson, Phd, University of Tennessee
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Steeves JA, Bassett DR, Fitzhugh EC, Raynor H, Cho C, Thompson DL. Physical Activity With and Without TV Viewing: Effects on Enjoyment of Physical Activity and TV, Exercise Self-Efficacy, and Barriers to Being Active in Overweight Adults. J Phys Act Health. 2016 Apr;13(4):385-91. doi: 10.1123/jpah.2015-0108. Epub 2015 Sep 17.
- Steeves JA, Bassett DR, Fitzhugh EC, Raynor HA, Thompson DL. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking. Int J Behav Nutr Phys Act. 2012 Aug 6;9:95. doi: 10.1186/1479-5868-9-95.
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
September 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 21, 2011
First Submitted That Met QC Criteria
April 25, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
November 9, 2012
Last Update Submitted That Met QC Criteria
October 10, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UTennessee
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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