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Physical Activity and Leisure-time Study (PALS) (PALS)

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ClinicalTrials.gov Identifier: NCT01342471
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : November 9, 2012
Last Update Posted : November 9, 2012
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Physical Activity Weight Behavioral: TV commercial stepping Behavioral: 30-min walk Phase 1

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  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: TV Commercial Stepping: Can America's Top Sedentary Activity be Made More Active
Study Start Date : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Behavioral: 30-min walk
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 Name: standard physical activity prescription
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.
Behavioral: TV commercial stepping
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 Name: novel exercise prescription



Primary Outcome Measures :
  1. Physical Activity (Steps/Day) [ Time Frame: 0 and 6 months ]
    Change in pedometer measured steps per day between 0 and 6 months


Secondary Outcome Measures :
  1. Total Energy Intake [ Time Frame: 0 and 6 months ]
    Change in total energy intake(kcals/day) between 0 and 6 months

  2. TV Related Energy Intake [ Time Frame: 0 and 6 months ]
    Change in energy intake (kcals/day) while watching TV between 0 and 6 months

  3. Weight [ Time Frame: 0 and 6 months ]
    Change in weight in kgs between 0 and 6 months

  4. 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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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342471


Locations
United States, Tennessee
HPER Building, 1914 Andy Holt Ave.
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Jeremy A Steeves, MS University of Tennessee
Study Chair: Dixie Lee Thompson, Phd University of Tennessee