Physical Activity and Leisure-time Study (PALS)

Physical Activity Clinical Trial

— PALS  

Official title:

TV Commercial Stepping: Can America's Top Sedentary Activity be Made More Active

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342471
• Other study ID #: UTennessee
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2011
• Last updated: October 10, 2012
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2012
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Activity
• Weight

Intervention

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
• 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

Locations

Country	Name	City	State
United States	HPER Building, 1914 Andy Holt Ave.	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity (Steps/Day)	Change in pedometer measured steps per day between 0 and 6 months	0 and 6 months	No
Secondary	Total Energy Intake	Change in total energy intake(kcals/day) between 0 and 6 months	0 and 6 months	No
Secondary	TV Related Energy Intake	Change in energy intake (kcals/day) while watching TV between 0 and 6 months	0 and 6 months	No
Secondary	Weight	Change in weight in kgs between 0 and 6 months	0 and 6 months	No
Secondary	TV Viewing Time	Change in self-reported TV viewing time per day between 0 and 6 months	0 and 6 months	No