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Physical ActivityPhase 1PALSNCT01342471

Physical Activity and Leisure-time Study (PALS)

A Phase 1 study testing TV commercial stepping and 30-min walk in people with Physical Activity and Weight, run by University of Tennessee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity, Weight
What is being tested?
TV commercial stepping and 30-min walk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
Sep 2010to Jun 2011
Phase
Phase 1
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 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • HPER Building, 1914 Andy Holt Ave.

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
TV commercial stepping, 30-min walk
Keywords
Physical activity intervention, walking, TV, sedentary
Medical subject headings
Motor Activity, Body Weight, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TV commercial steppingBehavioural

    Also called novel exercise prescription

    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 walkBehavioural

    Also called standard physical activity prescription

    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

Study groups in NCT01342471
Study groupRoleWhat they receive
30-min walkActive comparatorInstructed 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.
Receives: Behavioral: 30-min walk
TV commercial steppingExperimentalInstructed 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.
Receives: Behavioral: TV commercial stepping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity (Steps/Day)

    Change in pedometer measured steps per day between 0 and 6 months

    Measured: 0 and 6 months

Secondary outcomes (4)

  1. Total Energy Intake

    Change in total energy intake(kcals/day) between 0 and 6 months

    Measured: 0 and 6 months

  2. TV Related Energy Intake

    Change in energy intake (kcals/day) while watching TV between 0 and 6 months

    Measured: 0 and 6 months

  3. Weight

    Change in weight in kgs between 0 and 6 months

    Measured: 0 and 6 months

  4. TV Viewing Time

    Change in self-reported TV viewing time per day between 0 and 6 months

    Measured: 0 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342471
Sponsor's protocol ID
UTennessee
Acronym
PALS
Status last verified
Oct 2012
First submitted
21 Apr 2011
Last updated
9 Nov 2012
Data monitoring committee
No

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.

    PubMed 26383783

  • 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.

    PubMed 22866941

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TV commercial stepping and 30-min walk in people with Physical Activity and Weight, run by University of Tennessee 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 9 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 9 Nov 2012. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2012). 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?

Physical Activity (Steps/Day) (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342471, which also lists 2 linked publications.

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 9 Nov 2012.

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